シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ) Overseas Jobs- Asia and USの求人一覧
全 153 件中 13 件 を表示しています
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CRA II or above ※Australia Office
This is a home-based position in our Australia Office. POSITION PURPOSE: To support project(s) as ICH E6 GCP definition of "Monitor" To ensure all designated clinical/site monitoring activities are conducted in highest quality standards To support project in capacity of "Project Manager Assistant" (PMA) as required Support in operations and/or business's continuality by undertaking tasks such as: Mentoring and training of new employees as required Support business development activities Review, revise and/or develop clinical operations service related work guides or site specific documents etc. RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Perform site selection, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project(s) in the capacity of Clinical Operations Manager (COM) and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company Support/Assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic and advanced GCP course Certificate in monitoring or equivalent training Experience and Skills Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 2 years direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of medical terminology and clinical/medical practices Basic understanding of cross-functional processes, clinical trial processes and regulatory environment Good computer/technology skills including MS Word, MS Excel, PowerPoint etc Effective written and verbal communication skills, preferably with good command of English in addition to local language Good team player with excellent interpersonal and organization skills Possess advanced monitoring skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required Ability to manage time/prioritize, multi-task, work independently and follow through with assigned tasks High integrity in personality and professionalism Positive attitude, with sense of responsibility and commitment to work Flexible to work requests and willing to to travel as required Possess strong work ethic and personal discipline, demonstrate willingness and aptitude to take up more responsibilities APPLICATION: Interested parties please apply via LinkedIn: (https://www.linkedin.com/jobs/cap/view/1961989194/?pathWildcard=1961989194&trk=mcm) 続きを見る
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Clinical Project Manager I ※Taiwan Office
This position will be based in our Taiwan Office POSITION PURPOSE: Undertake the role of Project Manager for designated project(s) and be responsible for overall project management from every aspect to ensure all deliverables are met and client is satisfied with the service delivery and results. Support in operations and/or business's continuality by undertaking tasks such as: 1. Mentoring and training of new employees as required 2. Support business development activities 3. Review, revise and/or develop Project Management related SOPs, work guides etc. RESPONSIBILITIES: Responsible to plan, initiate, develop and organize clinical trials in accordance to the highest standards required in ICH E6 GCP, regulatory compliance, investigator integrity and compliance with the study requirements Responsible to lead and motivate project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor's expectation, under the supervision of project manager(s) Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved Responsible to lead project team(s), sponsor and vendors, pertaining to logistics management, clinical supplies and investigational product logistics, systems set up and/or any other requirements, are in place to ensure swift study start up Manage/support project(s) in the capacity of "Project Manager" (PM) and/or "Clinical Project Leader" (CPL) and/or relevant functional lead, undertake all or partial responsibilities and tasks as designated by the Company Develop and oversee applicable clinical systems are accurately set up and maintained in a timely manner, to track the compliance, finance status and performance of the project and site(s) within project timeline, so as to report appropriately to sponsor and internal management Support and/or conduct monitoring and co-monitoring activities, as required Support/assist in feasibility studies, site and investigator identification as required Overall responsible to ensure appropriate project files are set up and maintained accurately and in timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements Coordinate and support/assist in Site and CRO audit or inspection as required Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Support business development activities (e.g. project bidding, RFI, RFP) as required Review, revise and/or develop Project Management related SOPs, work guides etc. REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic and/or advanced GCP course Certificate in monitoring or basic clinical trial management courses Experience and Skills Minimum 5 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3 years direct experience in clinical project planning, coordination and management, with multi-national trial exposure Preferably has experience in coordination and/or preparation for site/CRO audit Preferably has experience in clinical study monitoring and co-monitoring Strong computer/technology skills including MS Word, MS Excel, PowerPoint etc. Effective written and verbal communication skills, preferably with good command of English in addition to local language Good understanding of cross-functional processes, clinical trial processes and regulatory environment Good organizational, leadership, negotiation and interpersonal skills Possess strong project management and coordination skills Advanced problem-solving and analytical skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required Demonstrate maturity, assertiveness and steadiness in managing conflict, challenges, decision making and risk management High integrity in personality and professionalism Ability to manage time/prioritize, multi-task, work independently and follow through with assigned tasks Possess strong sense of responsibility, dedication with strong work ethic and personal discipline Positive and demonstrate enthusiasm in up taking of new challenges and responsibilities Demonstrate flexibility and willing to travel as required APPLICATION: Interested parties please apply via LinkedIn: https://www.linkedin.com/jobs/cap/view/1758290198/?pathWildcard=1758290198&trk=mcm 続きを見る
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Clinical Research Associate I, II, Sr. ※Korea Office
This is a permanent position based in our Korea Office. POSITION PURPOSE: To support project(s) as ICH E6 GCP/applicable local GCP definition of “Monitor” To ensure all designated clinical/site monitoring activities are conducted in highest quality standards To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) To support study start up activities to ensure on-time start up and initiation of the study as possible To assist project team in all project related administrative tasks including status and financial tracking To support project in capacity of “Clinical Trail Assistant(CTA)” as required To provide relevant support and assistance whenever required by the company and project team RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor’s and/or company’s standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company Support/assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements (CRA II, Sr. CRA) Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required (Sr. CRA) Support business development activities (e.g. project bidding, RFI, RFP) as required (Sr. CRA) Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc. (Sr. CRA) Support Company’s operations by supporting orientation and applicable training for new employees as required (Sr. CRA) Support/assist in regulatory research/ consultancy tasks in relation to clinical trial planning, conduction and product application/ registration REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills CRA I - Minimum 1 years, CRA II – Minimum 3 years, Sr.CRA - Minimum 5 years of Relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Strong computer/technology skills including MS Word, MS Excel and PowerPoint Effective written and verbal communication skills, preferably with good command of English in addition to local language Good team player with excellent interpersonal and organization skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required High integrity in personality and professionalism Ability to manage time/prioritize, multitask, work independently and follow through with assigned tasks Flexible to work requests and willing to travel as required Possess strong work ethic and personal discipline, demonstrate willingness to learn APPLICATION: Interested parties please apply via LinkedIn: https://www.linkedin.com/jobs/cap/view/1758708491/?pathWildcard=1758708491&trk=mcm 続きを見る
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Clinical Project Manager ※Korea Office
This is a permanent position based in our Korea Office. POSITION PURPOSE: Undertake the role of Project Manager for designated project(s) and be responsible for overall project management from every aspect to ensure all deliverables are met and client is satisfied with the service delivery and results. Support in operations and/or business's continuality by undertaking tasks such as: 1. Mentoring and training of new employees as required 2. Support business development activities 3. Review, revise and/or develop Project Management related SOPs, work guides etc RESPONSIBILITIES: Responsible to plan, initiate, develop and organize clinical trials in accordance to the highest standards required in ICH E6 GCP, regulatory compliance, investigator integrity and compliance with the study requirements Responsible to lead and motivate project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor's expectation, under the supervision of project manager(s) Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved Responsible to lead project team(s), sponsor and vendors, pertaining to logistics management, clinical supplies and investigational product logistics, systems set up and/or any other requirements, are in place to ensure swift study start up Manage/support project(s) in the capacity of "Project Manager" (PM) and/or "Clinical Project Leader" (CPL) and undertake all or partial responsibilities and tasks as designated by the Company and in compliance to ICH E6 GCP, applicable local regulatory and project requirements Develop and oversee applicable clinical systems are accurately set up and maintained in a timely manner, to track the compliance, finance status and performance of the project and site(s) within project timeline, so as to report appropriately to sponsor and internal management Support and/or conduct monitoring and co-monitoring activities, as required Support/assist in feasibility studies, site and investigator identification as required Overall responsible to ensure appropriate project files are set up and maintained accurately and in timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements Coordinate and support/assist in Site and CRO audit or inspection as required Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Support business development activities (e.g. project bidding, RFI, RFP) as required Review, revise and/or develop Project Management related SOPs, work guides etc. REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic and advanced GCP courses Certificate in advanced monitoring and advance project management courses Experience and Skills Minimum 5 year experience in clinical research in healthcare, pharmaceutical and/or CRO industry Minimum 1 years’ direct experience of project management as a project manager, an operational team lead or a project assistant in the above industry Preferably has experience in clinical study monitoring and co-monitoring Experience in coordination and preparation for site/CRO audit Good understanding of cross-functional processes, clinical trial processes and the regulatory environment Strong computer/technology skills including MS Word, MS Excel and PowerPoint Effective written and verbal communication skills, preferably with good command of English in addition to local language Good organizational, leadership, negotiation and interpersonal skills Advanced problem-solving and analytical skills APPLICATION: Interested parties please apply via LinkedIn: https://www.linkedin.com/jobs/cap/view/1758708491/?pathWildcard=1758708491&trk=mcm 続きを見る
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Medical Writing Leader ※Korea Office
This is a permanent position based in our Korea Office. POSITION PURPOSE: Undertake the role of Medical writing for designed project(s) and be responsible for overall scripts from every aspect to ensure all deliverables are met and client is satisfied with the service delivery and results. Support assigned tasks by company to ensure operations’ continuality as required, including but not limited to: Mentoring and training of new employees as required. RESPONSIBILITIES: Responsible as functional leader, to work collaboratively with other operational project team to ensure seamless cross-functional communication/documentation and that the project related activities are conducted in the highest quality standards, in compliance with ICH E6/local GCP and applicable local regulatory requirements as well as to meet/exceed sponsor’s expectation. Write and edit clinical documents and submission to the sponsor Prepare protocols, clinical study reports, integrated summaries, all types of regulatory-agency submissions and medical writing as required Analysis and interpretation of clinical trial data in medical points of view Ensure quality of the documents & manage the document review process Ensure there is appropriate compliances with GCP, SOPs, guidelines and regulatory requirements Ensure compilation of appendices to trial reports Participate in project team meetings to provide input regarding deliverables, timelines, and processes Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients Performs other duties as requested by management Support in review/revision/development of medical writing related SOPs., work guides etc Support Company’s operation by assisting/coordinating and conducting orientation and applicable training for new employees as required Coordinate and support/Assist in site and CRO Audit or inspection as required. REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy, or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic and/or advanced GCP courses Certificate in SOP training Experience and Skills Minimum 5~6 years regulatory writing experience in clinical research, in healthcare, pharmaceutical CRO industry and/or related industry Qualified candidates must have experience writing protocols and protocol amendments, clinical study reports, investigator brochures, and all types of regulatory agency submissions Solid knowledge of the clinical development process, Good Clinical Practices, and the Medical Writing process Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature Proficiency using an electronic document management system including MS office applications Strong analytical ability to interpret clinical data Solid understanding of the requirements of regulatory writing, including ICH Guidelines Good Organizational, leadership and interpersonal Skills. Possess strong sense of responsibility, dedication with strong work ethic and personal discipline APPLICATION: Interested parties please apply via LinkedIn: https://www.linkedin.com/jobs/cap/view/1758708491/?pathWildcard=1758708491&trk=mcm 続きを見る
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Japanese Translator ※Beijing, China Office
This position will be based in our Beijing Office in China POSITION PURPOSE: Responsible to translate and communicate information during executing regulatory operations in assigned projects to ensure regulatory compliance to all standards and regulations. RESPONSIBILITIES: Translate status and progress of all related tasks including documentation, email, submission, review and approval; Review, edit and proofread documentation as applicable, to ensure good quality standard documents for submission; Participate as an active team member of local/regional project teams as required Assist to translate Clinical Monitoring related SOPs, work guides etc. Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Other ad-hoc assignment. REQUIREMENTS: Qualifications Minimum bachelor degree (major in Japanese Professional) from a recognized institution, and/or equivalent combination of training and experience. Preferably in the Pharmaceutical Industry background. Experience and Skills Minimum 3 years direct experience in Japanese Professional. Regulatory Authorities experience is optional, preferably in the Pharmaceutical Industry; Good understanding of cross-functional processes, clinical trial processes and the regional regulatory environment Strong computer/technology skills including MS Word, MS Excel and PowerPoint Proficient in Japanese, with effective written and verbal communication skills in Japanese in addition to local language Good organizational, leadership, negotiation and interpersonal skills Good analytical and problem-solving capabilities Advanced clinical study monitoring skills Possess good people management skills and is able to motivate, encourage and inspire project team members to excel, in order to meet clients' expectations Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required Demonstrate maturity, assertiveness and steadiness in managing conflict, challenges, decision making and risk management High integrity in personality and professionalism Ability to manage time/prioritize, multi-task, work independently and follow through with assigned tasks Possess strong sense of responsibility, dedication with strong work ethic and personal discipline and aptitude to take up on more responsibilities and challenges Constantly demonstrate stable and good performance Demonstrate flexibility and creativity in conflict management and negotiation APPLICATION: Please send you application with full resume to yihua-xiao@cmicgroup.com. 続きを見る
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Research Analyst (multiple positions) ※US Office
POSITION PURPOSE: The Research Analyst will perform lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Conduct Bio-analysis validation and sample analysis independently. Conduct Pre-Study with minimal supervision. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records. Provide direction and technical assistance to lesser-skilled team members. Assist with SOP/SWP preparation and other technical related documents including client communications. Perform other routine laboratory duties as deemed necessary RESPONSIBILITIES： Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies. Use and properly maintain lab instrument and equipment appropriately for assigned tasks. Conduct Bio-analysis validation and sample analysis independently meeting company quality standards. Conduct pre-study method development with minimal supervision. Assist Group Leader with Plan and Report preparation. Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs. Proficient troubleshooting skills. Maintain clean and safe lab work environment. Assist with SOP/SWP preparation and other technical related documents. Attend and participate in trainings, project meetings, etc. Contribute to a cohesive team environment. Communicate effectively with management, other units, coworkers and clients. Participate in lab duties such as lab clean up, and instrument routine maintenance. Maintain proprietary and confidential information. Assumes other activities and responsibilities as assigned. REQUIREMENTS： Qualifications • 2+ years working in regulated laboratory environment; GLP BioA Lab highly preferred. • B.S. in related field (i.e. Chemistry, Biochemistry), M.S. preferred, or Equivalent. Experience and Skills Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies. Use and maintain lab equipment appropriately for assigned tasks. Utilize scientific theory with proper skills (i.e. LC-MS/MS, HPLC, MSD) Maintain quality execution and work. Proficient troubleshooting skills. Ability to handle confidential information. Demonstrated effective oral and written communication skills. Good team player. Effective time management skills; complete work in a timely manner (i.e. maintain timelines). Proficient in MS Office and to be adept at learning new systems. APPLICATION : Interested parties please send your application via email toHR@cmicgroup.com 続きを見る
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CPS I/II ※Singapore Office
This is a 6-month contract position based in the Singapore Office. The type of contract could be converted to Permanent position after CPS performance review. POSITION PURPOSE: 1. To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) 2. To support study start up activities to ensure on-time start up and initiation of the study as possible 3. To assist Project Manager(s) and project team(s) in project administrative tasks and finance tracking, as required 4. To support project as per designated and required 5. To provide relevant support and assistance whenever required by the Company and project team(s) RESPONSIBILITIES: Responsible to work collaboratively with project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor's expectation, under the supervision of project manager(s) Responsible to work closely with project team(s) and project manager(s) to oversee daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved Responsible to work closely with project team(s), project manager(s), external parties (including sponsor), to support start up activities (such as vendor management, logistics management, clinical supplies and investigational product logistics as well as systems set up) to ensure swift study start up Support project(s) as per assigned capacity and undertake all or partial responsibilities and tasks, whenever designated by Project Manager Support project team(s) in developing and accurately updating/maintaining of clinical or relevant systems to track the compliance, finance status and performance of the project and site(s) within project timeline Support and/or conduct monitoring and co-monitoring activities, as required, under the supervision of project manager(s), CPL(s), functional lead(s) Support project team(s) in developing , compiling and/or reviewing of all project-related regulatory, monitoring and administrative documents as required, under supervision of project manager(s), CPL(s), functional lead(s) Support/assist in feasibility studies, site and investigator identification as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements Support/assist in regulatory search in related to clinical trial planning, conducting REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses ＊For this position, the company is not able to sponsor for the Employment Pass to work in Singapore. For those who are seeking to return to Singapore, this would be a good opportunity to contribute your skills and experience. Experience and Skills Minimum 2 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 1 year direct experience in assisting clinical project planning, coordinating and management Strong computer/technology skills including MS Word, MS Excel, PowerPoint etc. Good written and verbal communication skills, preferably with good command of English in addition to local language Good interpersonal and organization skills Basic understanding of cross-functional processes, clinical trial processes and regulatory environment Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required Ability to multi-task and follow through with assigned tasks Positive and demonstrate enthusiasm in learning and taking up new challenges APPLICATION: Interested parties please send your application via email to: Name: Tey Hweehwee Email: hweehwee-tey@cmicgroup.com 続きを見る
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CRA I/II ※Philippines Office
This is a 6-month contract home-based position in Philippines. The type of contract could be converted to Permanent position after CRA performance review. POSITION PURPOSE: To support project(s) as ICH E6 GCP/applicable local GCP definition of “Monitor". To ensure all designated clinical/ site monitoring activities are conducted in highest quality standards To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) To support study start up activities to ensure on-time start up and initiation of the study as possible To assist project team in all project related administrative tasks including status and financial tracking To support project in capacity of “Clinical Trail Assistant (CTA)” as required To provide relevant support and assistance whenever required by the company and project team RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements. Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor’s and/or company’s standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company Support/assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc. REQUIREMENTS: Qualifications: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 1 years direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Strong interpersonal, problem-solving, organization and time management skills Ability to produce meticulous and accurate work under pressure and stringent timelines Able to work independently and willingness to travel Strong computer/technology skills including MS Word, MS Excel and PowerPoint Good written and verbal communication skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Good team-player Ability to multi-task and follow through with assigned tasks Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations APPLICATIONS: Interested parties please apply via email. Responsible Person Contact details : Name: My Ha Email: tramy-hathi@cmicgroup.com 続きを見る
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Clinical Research Associate I or II※Thai Office
This is a 6-month contract home-based position in Thailand. The type of contract could be converted to Permanent position after CRA performance review. POSITION PURPOSE: To support project(s) as ICH E6 GCP/applicable local GCP definition of “Monitor” To ensure all designated clinical/ site monitoring activities are conducted in highest quality standards To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) To support study start up activities to ensure on-time start up and initiation of the study as possible To assist project team in all project related administrative tasks including status and financial tracking To support project in capacity of “Clinical Trail Assistant (CTA)” as required To provide relevant support and assistance whenever required by the company and project team RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor’s and/or company’s standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company Support/assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc. REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 1 years direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Strong interpersonal, problem-solving, organization and time management skills Ability to produce meticulous and accurate work under pressure and stringent timelines Able to work independently and willingness to travel Strong computer/technology skills including MS Word, MS Excel and PowerPoint Good written and verbal communication skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Good team-player Ability to multi-task and follow through with assigned tasks Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations APPLICATIONS: Interested parties please apply via email. Responsible Person Contact details Name: My Ha Email: tramy-hathi@cmicgroup.com 続きを見る
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CRA I/II※Malaysia
This is a 6-month contract home-based position in Malaysia. The type of contract could be converted to permanent position after CRA performance review. POSITION PURPOSE: To support project(s) as ICH E6 GCP/applicable local GCP definition of “Monitor” To ensure all designated clinical/ site monitoring activities are conducted in highest quality standards To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) To support study start up activities to ensure on-time start up and initiation of the study as possible To assist project team in all project related administrative tasks including status and financial tracking To support project in capacity of “Clinical Trail Assistant (CTA)” as required To provide relevant support and assistance whenever required by the company and project team RESPONSIBILITIES: Responsible for preparing, organizing, managing and monitoring clinical trials in accordance with the highest standards Responsible for performing all monitoring aspects of clinical trials as stated in ICH E6 GCP/applicable local GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Perform site selection, initiation, monitoring and close-out visits in accordance with sponsor’s and/or company’s standard operating procedures (SOPs) and study requirements Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required Support in safety reporting to regulatory and/or ethics committee as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for site as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project in the capacity of Clinical Research Associate, Clinical Trial Assistant and/or designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the company Support/assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP/applicable local GCP, applicable local regulatory and project requirements Support Company’s operations by assisting/coordinating and conducting orientation and applicable training for new employees as required Review, revise and/or develop Clinical Monitoring related SOPs, work guides etc... REQUIREMENTS: Qualifications Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP courses Certificate in monitoring or equivalent training Experience and Skills Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1-2 years direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Experience and Skills Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or 1-2 years direct experience as monitor in clinical studies Preferably has experience in clinical study monitoring Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations Strong interpersonal, problem-solving, organization and time management skills Ability to produce meticulous and accurate work under pressure and stringent timelines Able to work independently and willingness to travel Strong computer/technology skills including MS Word, MS Excel and PowerPoint Good written and verbal communication skills Self-initiative to perform duties Meticulous and able to work in a fast-paced environment Good team-player Ability to multi-task and follow through with assigned tasks Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations APPLICATIONS: Interested parties please apply via email. Responsible Person Contact details Name: My Ha Email: tramy-hathi@cmicgroup.com 続きを見る
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Clinical Trial Assistant (CTA)※Hong Kong Office
POSITION PURPOSE: To support project management, clinical monitoring and/or regulatory affairs operations in all aspects of the project(s) To support study start up activities to ensure on-time start up and initiation of the study as possible To assist project team(s) in all project related administrative tasks including status and financial tracking To support project in capacity of "Clinical Trial Assistant " (CTA) or "Clinical Project Specialist " (CPS) as required To provide relevant support and assistance whenever required by the Company and project team(s) RESPONSIBILITIES: Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required Support in safety reporting to regulatory and/or ethics committee and/or Investigator as required Support in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Support/assist in feasibility studies, site and investigator identification as required Manage/support project(s) in the capacity of Clinical Trial Assistant ( CTA) and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company Support/Assist in Site and CRO audit or inspection as required Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements Maintenance and support study document filing/upload to e-TMF system and internal document QC related process Support the organization of the office monthly operations meeting Support internal/external study finance process Support business development activities (e.g. search new project related information [AD] Handles and/or coordinates office administrative work, including purchasing, policy dissemination, office operations/maintenance, Legal and IT support. Ensure all transactions are reasonable, appropriate, and necessary [AD] Provide support to management on all finance and administration matters. REQUIREMENTS: Qualifications Minimum diploma or bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience Certificate in basic GCP course Experience and Skills Graduated or 1 year working experience in the related industry Strong computer/technology skills including MS Word, MS Excel, PowerPoint Good written and verbal communication skills, preferably with good command of English in addition to local language Good organizational and interpersonal skills Self-initiative to perform duties Ability to multi-task and follow through with assigned tasks APPLICATIONS: Interested parties please apply via LinkedIn. (https://www.linkedin.com/jobs/cap/view/1961989194/?pathWildcard=1961989194&trk=mcm ) 続きを見る
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Associate Director (Small Molecule) ※IL, US office
POSITION PURPOSE: The Associate Director is an inspiration to the group, motivating and leading laboratory activities and functions. In this role, you are responsible leading teams for successful study execution and meeting laboratory overall objectives and timelines. Actively participating in business discussions, service promotions, and new service creation and implementation. Ensure study executions in compliance with GxP and 21 CFR Part 11; proactively identify laboratory issues and make recommendations. Ensure your respective lab operations for each team are performed effectively and provide directions for remedy actions. Maintain effective daily lab operations including providing direction, mentoring and coaching to lesser-skilled teams of analysts to build skillsets. You will also serve as a Principal Investigator (PI); managing a team of analysts and achieving unit objectives within time constraints by successfully managing and conducting multiple study initiations, executions and completions within designated timelines and budget, and meeting company quality standards. You are expected to recommend alternative methods for solving a problem. Effectively communicate with clients; present experimental results to internal and external clients. Document work and maintain study documentation and lab records. You will participate in the quotation process, SOP and other technical related document preparation. RESPONSIBILITIES: Ensure GxP (when applicable) and 21 CFR part 11 compliance for Bioanalysis. Ensure CMIC internal procedures and policies are properly followed by your team members. Provide necessary training for staffs. Ability to assume PI role in accordance with GxP requirements and participate in lab activities. Ability to manage a group of analysts and PIs. Work with Business Development to insure project management is aligned with sponsors and regulatory requirements. Ability to present experimental results during group meetings and to CMIC management team. Proficient communication skills with sponsors, lab staffs, QA and officers. Provide written summaries of work for presentation to clients and regular updates to senior management team. Must effectively manage the timelines for his/her groups, and achieve project objectives within time constraints. Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems. Manage, mentor and coach a team of analysts. Build and maintain a cohesive team. Perform evaluations and set goals; ensure unit goals are being met. Address performance related concerns as need arise. Lead lab improvement including operation efficiency. Participate in the quotation process; audit process; audit visits; client visits. May participate in interview process. Effective time management, organization, and teamwork skills as well as attention to detail with the ability to multitask. Responsible for confidential and time sensitive material. Participate in marketing efforts through publications, presentations, posters. Recommend and develop technology innovation. Assist with new service creation. Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications Minimum 7+ years experience within a BioA laboratory with solid publication track record; and at least 2 years leadership and experience. PhD in related field (i.e. chemistry, biochemistry, biotechnology, pharmacognosy) or Equivalent Experience and Skills Proficient in method development, method validation, bio-sample preparation and study sample analysis. LC-MS/MS instrument Proficient troubleshooting skills. Maintain quality execution and work. Demonstrated effective oral and written communication skills. Staff, team management with the ability to mentor, coach and build analysts skillsets. Effective time management skills; complete unit goals in a timely manner and within allotted budget. (i.e. maintain timelines). Manage lab equipment usage and maintain lab equipment appropriately for assigned tasks. Understand and mentor GxP requirements, SOP/SWPs and related lab procedures; safety policies and company policies. Ability to proactively prevent non-compliant issues in lab operations. Ability to handle confidential information. Proficient presentation skills. Ability to independently create publications, presentations and posters. Proficient in MS Office and to be adept at learning new systems. APPLICATION: Interested parties please send your application via email to Denise Washick (Denise-Washick@cmicgroup.com). 続きを見る
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