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 147 件中 7 件 を表示しています
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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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Research Analyst ※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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CRA I/II ※ Malaysia Office
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 minimum 1 year 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 to: Responsible Person: My Ha Email: tramy-hathi@cmicgroup.com 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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Clinical Research Associate (CRA) ※Hong Kong
This is a home-based full-time position in Hong Kong 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 conduct project with CRA role in the project activity 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 performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance 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 Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards Planning, 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 Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Manage/support project(s) in the capacity of CRA role 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 Support business development activities (e.g. search new project related information) as required Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration Proactively identify and facilitate resolution of complex study problems and issues. Actively work towards achieving good personal relationships with the project Team members REQUIREMENTS: Qualifications Minimum 2 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research Preferably has experienced in clinical study monitoring Experience and Skills 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 Application: Interested parties please apply via LinkedIn https://www.linkedin.com/jobs/cap/view/2159733761/?pathWildcard=2159733761&trk=mcm 続きを見る
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Clinical Research Associate ※Australia
This is a home-based full-time position in 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 conduct project with CRA role in the project activity 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 performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance 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 Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards Planning, 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 Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Manage/support project(s) in the capacity of CRA role 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 Support business development activities (e.g. search new project related information) as required Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration Proactively identify and facilitate resolution of complex study problems and issues. Actively work towards achieving good personal relationships with the project Team members REQUIREMENTS: Qualifications Minimum 2 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research Preferably has experienced in clinical study monitoring Experience and Skills 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 Application: Interested parties please apply via LinkedIn https://www.linkedin.com/jobs/cap/view/2159733761/?pathWildcard=2159733761&trk=mcm 続きを見る
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Clinical Research Associate I or II ※ Singapore
This is a 6-month contract position in our Singapore Office. 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 year 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 to: Responsible Person: My Ha Email: tramy-hathi@cmicgroup.com 続きを見る
全 147 件中 7 件 を表示しています