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 8 件中 8 件 を表示しています
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Associate Director/Large Molecule Group ※CMIC, Inc.
POSITION PURPOSE: The Associate Director/Large Molecule is responsible for leading the large molecule teams for successful study execution and meeting laboratory overall objectives and timelines. Actively participates in business discussions, service promotions, and new service creation Will 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. Effectively communicate with clients; present experimental results to internal and external clients. Document work and maintain study documentation and lab records. 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 • Ability to assume PI role in accordance with GxP requirements and participate in lab activities. • Proficient communication skills with sponsors, lab staffs, QA and officers. • 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. • Lead lab improvement including operation efficiency. • 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. • Recommend and develop technology innovation. Assist with new service creation. • Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications 7+ years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with Instrument hands-on experience of ECL - MSD S600, ELISA – absorbance, fluorescence, luminescence; qPCR – Quant Studio 5; and or Cytoflex – Flow Cytometer for large molecule. Management Duties. M.S. in related field or Equivalent. PhD preferred. Experience and Skills Proficient in method development, method validation, bio-sample preparation and study sample analysis. ・ELISA – absorbance, fluorescence, luminescence ・ECL - MSD S600 ・qPCR – Quant Studio 5 ・Cytoflex – Flow Cytometer ・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. ・Proficient in MS Office and to be adept at learning new systems APPLICATION: Application method Interested parties please apply via HR@cmicgroup.com Responsible Person Contact details Name: Denise Washick Email: Denise-Washick@cmicgroup.com 続きを見る
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Research Analyst【CMIC, Inc.】
Research Analyst – 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. Maintain a safe environment. Requirements: Bachelor’s or foreign degree equivalent in Chemistry, Food Science, Engineering, Food Technology or related field and 1 year of experience in the job offered or experience working in a regulatory laboratory environment. Special skills: 1 year of experience in LC-MS/MS and/or UHPLC-UV; UHPLC-FD; understanding GLP requirements and SOP/SWPs; and utilizing analytical techniques to perform sample analysis. Worksite Location - 2860 Forbs Ave., Hoffman Estates, IL 60192 Any Applicant who is interested in this position may apply by regular mail to: D. Washick CMIC, Inc. 2860 Forbs Ave. Hoffman Estates, IL 60192 続きを見る
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Group Leader ※US Office
POSITION PURPOSE: The Group Leader (C-1) is an inspiration to the group, motivating and leading group activities and functions. In this role, you are responsible for leading and performing laboratory activities in accordance with applicable Methods, Plans, SOPs/SWPs, GxP regulatory guidelines and 21 CFR Part 11 independently. You will 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 client timelines and budget, 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. Maintain effective daily lab operations including providing direction, mentoring and coaching to lesser-skilled teams of analysts to build skillsets. You will participate in the quotation process, SOP and other technical related document preparation and training; participate in marketing efforts, publications, presentations and posters. RESPONSIBILITIES: Comply and mentor a team of analysts with GLP requirements, Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies. Serve as a Principal Investigator (PI) successfully managing and conducting multiple study initiations, executions and completions within the time constraints while still maintaining the quality standards of the company. Ability to present experimental results during group, team and management meetings. Provide written summaries of work for presentation to clients and communicate directly with clients. 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. Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems. Actively participate in lab improvement including operation efficiency. Participate in the quotation process; audit process; audit visits; client visits. Professional communication (both oral and written) with clients and management. 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. Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications: 5 years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with instrument hands-on experience of LC-MS/MS and/or UHPLC-UV; UHPLC-FD for small molecule. Supervisory duties M.S. in related field or Equivalent. PhD preferred. Experience and skills: Proficient in method development, method validation, bio-sample preparation and study sample analysis. LC-MS/MS (SM) UHPLC-UV (SM) UHPLC-FD (SM) 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. Proficient in MS Office and to be adept at learning new systems. APPLICATIONS: Application method Interested parties please apply via HR@cmicgroup.com Responsible Person Contact details Name: Denise Washick Email: Denise-Washick@cmicgroup.com 続きを見る
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Clinical Research Associate (CRA) I or II※Thailand
POSITION PURPOSE: 1. To support project(s) as ICH E6 GCP definition of "Monitor" 2. To ensure all designated clinical/site monitoring activities are conducted in highest quality standards And for CRA II: 3. To conduct project with Lead CRA role in the project activity as required 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 Review, revise and/or develop clinical operations service related work guides or site specific documents etc. RESPONSIBILITIES AND DUTIES: 1. 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 2. Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring and close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards 3. 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 4. 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 5. Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required 6. Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company 7. Support/Assist in Site and CRO audit or inspection as required 8. Support business development activities (e.g. search new project related information. As for senior CRA, project bidding also) as required 9. Proactively identify and facilitate resolution of complex study problems and issues. 10. Actively work towards achieving good personal relationships with the project Team members And for CRA II, 11. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration REQUIRED EDUCATION AND QUALIFICATIONS: 1. For CRA I: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience For CRA II: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience institution, and/or equivalent combination of training and experience 2. Certificate in basic GCP course 3. Certificate in monitoring or equivalent training WORK EXPERIENCE, SKILLS AND KNOWLEDGE: 1. CRA I: Minimum 1 year 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 CRA II: Minimum 3 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 2. CRA I: Preferably has experience in clinical study monitoring or coordination CRA II: Preferably has experience in clinical study monitoring 3. Good knowledge of medical terminology and clinical/medical practices 4. Basic understanding of cross-functional processes, clinical trial processes and regulatory environment 5. Good computer/technology skills including MS Word, MS Excel, PowerPoint etc. 6. Effective written and verbal communication skills, preferably with good command of English in addition to local language 7. Good team player with excellent interpersonal and organization skills 8. CRA I: Possess basic monitoring skills CRA II: Possess advanced monitoring skills *APPLICATION:* Interested parties please apply to: munyee-wan@cmicgroup.com 続きを見る
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Clinical Research Associate (CRA) I or II※Malaysia
POSITION PURPOSE: 1. To support project(s) as ICH E6 GCP definition of "Monitor" 2. To ensure all designated clinical/site monitoring activities are conducted in highest quality standards And for CRA II: 3. To conduct project with Lead CRA role in the project activity as required 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 Review, revise and/or develop clinical operations service related work guides or site specific documents etc. RESPONSIBILITIES AND DUTIES: 1. 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 2. Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring and close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards 3. 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 4. 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 5. Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required 6. Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company 7. Support/Assist in Site and CRO audit or inspection as required 8. Support business development activities (e.g. search new project related information. As for senior CRA, project bidding also) as required 9. Proactively identify and facilitate resolution of complex study problems and issues. 10. Actively work towards achieving good personal relationships with the project Team members And for CRA II, 11. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration REQUIRED EDUCATION AND QUALIFICATIONS: 1. For CRA I: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience For CRA II: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience institution, and/or equivalent combination of training and experience 2. Certificate in basic GCP course 3. Certificate in monitoring or equivalent training WORK EXPERIENCE, SKILLS AND KNOWLEDGE: 1. CRA I: Minimum 1 year 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 CRA II: Minimum 3 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 2. CRA I: Preferably has experience in clinical study monitoring or coordination CRA II: Preferably has experience in clinical study monitoring 3. Good knowledge of medical terminology and clinical/medical practices 4. Basic understanding of cross-functional processes, clinical trial processes and regulatory environment 5. Good computer/technology skills including MS Word, MS Excel, PowerPoint etc. 6. Effective written and verbal communication skills, preferably with good command of English in addition to local language 7. Good team player with excellent interpersonal and organization skills 8. CRA I: Possess basic monitoring skills CRA II: Possess advanced monitoring skills APPLICATION: Interested parties please apply to: munyee-wan@cmicgroup.com 続きを見る
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Clinical Research Associate (CRA) II or Sr ※Singapore
POSITION PURPOSE: 1. To support project(s) as ICH E6 GCP definition of "Monitor" 2. To ensure all designated clinical/site monitoring activities are conducted in highest quality standards 3. To conduct project with Lead CRA role in the project activity as required 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 Review, revise and/or develop clinical operations service related work guides or site specific documents etc. RESPONSIBILITIES AND DUTIES: 1. 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 2. Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring and close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards 3. 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 4. 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 5. Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required 6. Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company 7. Support/Assist in Site and CRO audit or inspection as required 8. Support business development activities (e.g. search new project related information. As for senior CRA, project bidding also) as required 9. Proactively identify and facilitate resolution of complex study problems and issues. 10. Actively work towards achieving good personal relationships with the project Team members 11. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration And for Senior CRA, 12. Support Company's operations by assisting/coordinating and conducting orientation, supporting orientation, oversight visit and applicable training for new employees as required 13. Support review, revise and/or develop Clinical operation related SOPs, work guides etc. 14. Support and/or conduct monitoring and Co-monitoring visit and internal documents QC process as required REQUIRED EDUCATION AND QUALIFICATIONS: 1. For CRA II: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience institution, and/or equivalent combination of training and experience For Senior CRA: Minimum bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience 2. Certificate in basic GCP course 3. Certificate in monitoring or equivalent training WORK EXPERIENCE, SKILLS AND KNOWLEDGE: 1. For CRA II: Minimum 3 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 For Senior CRA: Minimum 5 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 4 years direct experience as monitor in clinical studies with good performance 2. For CRA II: Preferably has experience in clinical study monitoring For Senior CRA: Experienced in coordination and preparation for site/CRO audit and has experience as a clinical lead or any other supervisory/leading role in clinical studies 3. Good knowledge of medical terminology and clinical/medical practices 4. For CRA II: Basic understanding of cross-functional processes, clinical trial processes and regulatory environment For Senior CRA: Good understanding of cross-functional processes, clinical trial processes and regulatory environment 5. Good computer/technology skills including MS Word, MS Excel, PowerPoint etc. 6. Effective written and verbal communication skills, preferably with good command of English in addition to local language 7. Good team player with excellent interpersonal and organization skills 8. For CRA II: Possess advanced monitoring skills For Senior CRA: Possess advanced monitoring skills and clinical trial management APPLICATION: Interested parties please apply to: munyee-wan@cmicgroup.com 続きを見る
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Associate Clinical Project Manager※Singapore
POSITION PURPOSE: 1. 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. 2. Support in operations and/or business's continuality by undertaking tasks such as: Mentoring and training of new employees as require Support business development activities Review, revise and/or develop Project Management related SOPs, work guides etc RESPONSIBILITIES AND DUTIES: 1. 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 for organization and management of project team and projects plans. Responsible for overseeing project execution and control activities. Responsible for planning, coordinating and managing the project in terms of resourcing, deliverables and timelines 2. 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 for developing and executing quality management measure defined in Project Management Plan by defining project quality standards and requirements to ensure expected quality performance deliverables are met. Responsible for identifying foreseeable/ potential risks/ compliance issues which might affect the project quality standards, requirements and quality deliverables and proactively mitigating the risks/ non-compliance. Responsible for providing training to the project team members to ensure the project team is fully aware of the defined quality standards, requirements and expected quality performance deliverables. 3. 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 for planning, coordinating and managing the project in terms of budget, quality, compliance, resourcing, deliverables and timelines. Responsible to ensure execution of appropriate communication channels and its documentation. 4. 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: Responsible to conduct project level meeting at the initiation of project. Prepare and maintain project matrix/ Gantt chart and review during vendor meetings. Manage scope of work and change in scope in consultation with the sponsor. Complete and provide ‘Vendor Feedback Form’, detailing the reviews of CMIC team and sponsor assessment at the end of project. 5. Manage/support project(s) in the capacity of "Project Manager" (PM) and/or “Project Leader” (PL) to undertake all or partial responsibilities and tasks as designated by the Company 6. 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: Responsible for establishment of project systems according to the project needs. Responsible for generating project reports and reviewing with internal project team members. Responsible for delivering project on time and within budget. Ensure that the project reports are shared with Sponsor (If applicable). 7. Support and/or conduct monitoring and co-monitoring activities, as required (Preferably) 8. Support/assist in feasibility studies, site and investigator identification as required (Preferably). 9. Responsible to ensure that overall, appropriate project files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements 10. Coordinate and support/assist in Site and CRO audit or inspection as required: Prepare functions and project team for regulatory inspections Perform activities/ tasks to prepare for regulatory inspections. Oversee and guide project team members during inspection. Review responses to inspection observations Coordinate with HOD of specific functions, identify/ specify responses i.e. root cause, Corrective Actions and Preventive Actions (CAPA) along with timelines of resolution Implement CAPA action items Follow-up of inspection reports/ inspection observations 11. Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required 12. Support business development activities (e.g. project bidding, RFI, RFP) as required: Provide realistic budget estimation on the project-related expenses according to study assumptions upon Request For Proposal (RFP) in reference to ‘Project Plan Development and Execution’. Manage, monitor, adjust and control the total budget for each project throughout the entire project duration. Escalate to the management and sponsor whenever there is any scope creep and unforeseeable or unplanned expenses to be incurred. Compile additional budget from various parties, including CMIC project team, site personnel, contractors and/or vendors. Trigger BD Personnel to discuss with the sponsor to request for additional budget’s approval and prepare necessary Change Order (CO) or contract addendum with relevant parties, whichever applicable. Arrange project meeting to inform the additional budget or CO to relevant project team members including contractors and/or vendors whenever there is any CO. Prepare, reconcile, analyse and report project financial performance and associated key performance indicators at predetermined intervals to the sponsor and/or to CMIC management. Review SOW on an ongoing basis and identify out of scope. Notify and work with BD personnel in the development of Change Order. Communicate with sponsor on Change Order. Assist BD personnel with developing and revising costing estimates, as necessary 13. Review, revise and/or develop Project Management related SOPs, work guides etc: Responsible for the development, amendment, execution and maintenance of Project Management Plan which is used to manage and control the execution of the project. REQUIRED EDUCATION AND QUALIFICATIONS: 1. Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience 2. Certificate in basic and advanced GCP course, in the applicable countries, or the equivalent internal training records 3. Certificate in advanced monitoring and/or project management courses 4. Has experience in a pharmaceutical/biotechnology setting including development of pharmaceutical products and/or medical equipment. Has in-depth knowledge/understanding of clinical development. WORK EXPERIENCE: 1. Minimum 4 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 2. Has experience in clinical study monitoring and co-monitoring (Preferably) 3. Experience in coordination and preparation for site/CRO/Regulatory authority audit (Preferably) APPLICATION: Interested parties please apply to: munyee-wan@cmicgroup.com 続きを見る
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Associate Manager, PM※Singapore
POSITION PURPOSE: 1. 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. 2. Support in operations and/or business's continuality by undertaking tasks such as: 1. Mentoring and training of new employees as require 2. Support business development activities -Review, revise and/or develop Project Management related SOPs, work guides etc RESPONSIBILITIES AND DUTIES: 1. 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 for organization and management of project team and projects plans. Responsible for overseeing project execution and control activities. Responsible for planning, coordinating and managing the project in terms of resourcing, deliverables and timelines 2. 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 for developing and executing quality management measure defined in Project Management Plan by defining project quality standards and requirements to ensure expected quality performance deliverables are met. Responsible for identifying foreseeable/ potential risks/ compliance issues which might affect the project quality standards, requirements and quality deliverables and proactively mitigating the risks/ non-compliance. Responsible for identifying foreseeable/ potential risks/ compliance issues which might affect the project quality standards, requirements and quality deliverables and proactively mitigating the risks/ non-compliance. Responsible for providing training to the project team members to ensure the project team is fully aware of the defined quality standards, requirements and expected quality performance deliverables. 3. 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 for planning, coordinating and managing the project in terms of budget, quality, compliance, resourcing, deliverables and timelines. Responsible to ensure execution of appropriate communication channels and its documentation. 4. 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: Responsible to conduct project level meeting at the initiation of project. Prepare and maintain project matrix/ Gantt chart and review during vendor meetings. Manage scope of work and change in scope in consultation with the sponsor. Complete and provide ‘Vendor Feedback Form’, detailing the reviews of CMIC team and sponsor assessment at the end of project. 5. Manage/support project(s) in the capacity of "Project Manager" (PM) or “Project Leader” (PL) to undertake all or partial responsibilities and tasks as designated by the Company 6. 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: Responsible for establishment of project systems according to the project needs. Responsible for generating project reports and reviewing with internal project team members. Responsible for delivering project on time and within budget. Ensure that the project reports are shared with Sponsor (If applicable). 7. Support and/or conduct monitoring and co-monitoring activities, as required (Preferably) 8. Support/assist in feasibility studies, site and investigator identification as required (Preferably). 9. Responsible to ensure that overall, appropriate project files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements 10. Coordinate and support/assist in Site and CRO audit or inspection as required: Prepare functions and project team for regulatory inspections Perform activities/ tasks to prepare for regulatory inspections. Oversee and guide project team members during inspection. Review responses to inspection observations Coordinate with HOD of specific functions, identify/ specify responses i.e. root cause, Corrective Actions and Preventive Actions (CAPA) along with timelines of resolution Implement CAPA action items Follow-up of inspection reports/ inspection observations 11. Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required 12. Support business development activities (e.g. project bidding, RFI, RFP) as required: Provide realistic budget estimation on the project-related expenses according to study assumptions upon Request for Proposal (RFP) in reference to ‘Project Plan Development and Execution’. Manage, monitor, adjust and control the total budget for each project throughout the entire project duration. Escalate to the management and sponsor whenever there is any scope creep and unforeseeable or unplanned expenses to be incurred. Compile additional budget from various parties, including CMIC project team, site personnel, contractors and/or vendors. Trigger BD Personnel to discuss with the sponsor to request for additional budget’s approval and prepare necessary Change Order (CO) or contract addendum with relevant parties, whichever applicable. Arrange project meeting to inform the additional budget or CO to relevant project team members including contractors and/or vendors whenever there is any CO. Prepare, reconcile, analyse and report project financial performance and associated key performance indicators at predetermined intervals to the sponsor and/or to CMIC management. Review SOW on an ongoing basis and identify out of scope. Notify and work with BD personnel in the development of Change Order. Communicate with sponsor on Change Order. Assist BD personnel with developing and revising costing estimates, as necessary 13. Review, revise and/or develop Project Management related SOPs, work guides etc: Responsible for the development, amendment, execution and maintenance of Project Management Plan which is used to manage and control the execution of the project. 14. Manage and develop a team of CTAs, CPSs, APMs and/or PMs as assigned by Company 15. Manage project(s) in the capacity of "Project Director" and undertake all or partial responsibilities and tasks as designated by the Company: Responsible for overseeing a number of Project Managers in every region for a multi-regional study to ensure that all deliverables from the study are met and that the client is satisfied with the service delivery and results. REQUIRED EDUCATION AND QUALIFICATIONS: 1. Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience 2. Certificate in basic and advanced GCP course, in the applicable countries, or the equivalent internal training records 3. Certificate in advanced monitoring and/or project management courses 4. Has experience in a pharmaceutical/biotechnology setting including development of pharmaceutical products and/or medical equipment. Has in-depth knowledge/understanding of clinical development. WORK EXPERIENCE: 1. Minimum 7 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry, or relevant experience or minimum 5 years direct experience as clinical project manager in multi-national clinical trials and/or ICCC trials 2. Has experience in clinical study monitoring and co-monitoring (Preferably) 3. Experience in coordination and preparation for site/CRO/Regulatory authority audit APPLICATION: Interested parties please apply to: munyee-wan@cmicgroup.com 続きを見る
全 8 件中 8 件 を表示しています