Ref #: 38055
Employment type: Permanent - Full-Time
Location: Taiwan, Home base
Posted: 02-Jun-2022
Description
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Clinical Trial Manager (Regional Role)" to work closely with our client, a leading pharmaceutical company.
Overview
- Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials.
- These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).
- This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners.
- Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable).
- Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL.
- Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out.
- Takes ownership for assigned responsibilities.
- Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader.
- Advanced is given assignments that are more complex and/or have a greater potential impact on business results.
- May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input.
- May contribute to process improvement and/or non-project work.
Key responsibilities
* Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
* Complies with relevant training requirements.
* Lead the Study Management Team including providing updates to all trial team members on deliverable status.
* Ensure availability of required reports to support real time tracking of trial status according to trial plan.
* Manage timely and accurate documentation and communication of trial progress.
* Ensure that the Study Management Team (SMT) operates in a constant state of inspection readiness.
* Act as primary contact for country and Regional staff.
* Act as primary contact for the local teams within GCDO.
* Partner with the Global Team Lead to execute and oversee central activities from planning, trial start-up, though the life of trial to close-out.
* Ensure issue escalation and drive issue resolution.
* Work closely with Trial Team to ensure CAOAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
* Contribute to data collection to support the site selection process.
* Participate in feasibility, providing recommendations as needed.
* Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level,
* Ensure the availability of robust recruitment/contingency plans are n place for each region.
* Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
* Perform Annual Quality Review of files, as appropriate.
* Ensure archiving and retention of documents per set requirements.
* Establish country budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
* Oversight of selected vendors and status of related deliverables.
* Review and approve assigned vendor invoices/spend.
* Monitor budgets and expenditures as expected per planned trial budget.
* Create and update trial-specific documents as required; including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
* Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
* Provide central documents required for HA/EC/IRB submission.
* Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
* Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
* Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
* Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
* Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
* Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
* Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
* Coordinate data cleaning with some supervision towards a timely and successful database lock.
* Act as central expert for assigned protocol(s).
* Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
* Contribute to process improvement and training, as applicable.
* Lead and/or participate in special initiatives, task forces, as assigned.
Required experience and qualifications
* 6 years clinical trial management experience in the pharmaceutical industry or CRO.
* Strong working knowledge of ICH-GCP, local laws and regulations.
* Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
* Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
* Effective leadership skills and ability to manage multiple stakeholders.
* Proven ability to lead a team through formation stages, up to operating as a high performing team.
* Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
* Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
* Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
* Strong project planning/management.
* Independent complex decision-making.
* Solution oriented and proactive risk identification and mitigation.
* Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System and willingness to learn new systems.
* Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
* Travel.
* Proficient in speaking and writing local country language and English.
* Effective verbal and written communication skills leading to successful team collaboration
* Strong decision-making. Solution oriented.
* Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
* Experience in developing presentations and presenting key information to stakeholders.
* Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob
Overview
- Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials.
- These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).
- This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners.
- Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable).
- Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL.
- Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out.
- Takes ownership for assigned responsibilities.
- Demonstrated competency to act as a backup or first point of contact in absence of the GCDO Trial Leader.
- Advanced is given assignments that are more complex and/or have a greater potential impact on business results.
- May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input.
- May contribute to process improvement and/or non-project work.
Key responsibilities
* Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
* Complies with relevant training requirements.
* Lead the Study Management Team including providing updates to all trial team members on deliverable status.
* Ensure availability of required reports to support real time tracking of trial status according to trial plan.
* Manage timely and accurate documentation and communication of trial progress.
* Ensure that the Study Management Team (SMT) operates in a constant state of inspection readiness.
* Act as primary contact for country and Regional staff.
* Act as primary contact for the local teams within GCDO.
* Partner with the Global Team Lead to execute and oversee central activities from planning, trial start-up, though the life of trial to close-out.
* Ensure issue escalation and drive issue resolution.
* Work closely with Trial Team to ensure CAOAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
* Contribute to data collection to support the site selection process.
* Participate in feasibility, providing recommendations as needed.
* Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level,
* Ensure the availability of robust recruitment/contingency plans are n place for each region.
* Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
* Perform Annual Quality Review of files, as appropriate.
* Ensure archiving and retention of documents per set requirements.
* Establish country budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
* Oversight of selected vendors and status of related deliverables.
* Review and approve assigned vendor invoices/spend.
* Monitor budgets and expenditures as expected per planned trial budget.
* Create and update trial-specific documents as required; including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
* Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
* Provide central documents required for HA/EC/IRB submission.
* Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
* Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
* Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
* Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
* Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
* Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
* Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
* Coordinate data cleaning with some supervision towards a timely and successful database lock.
* Act as central expert for assigned protocol(s).
* Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
* Contribute to process improvement and training, as applicable.
* Lead and/or participate in special initiatives, task forces, as assigned.
Required experience and qualifications
* 6 years clinical trial management experience in the pharmaceutical industry or CRO.
* Strong working knowledge of ICH-GCP, local laws and regulations.
* Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
* Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
* Effective leadership skills and ability to manage multiple stakeholders.
* Proven ability to lead a team through formation stages, up to operating as a high performing team.
* Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
* Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
* Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
* Strong project planning/management.
* Independent complex decision-making.
* Solution oriented and proactive risk identification and mitigation.
* Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System and willingness to learn new systems.
* Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
* Travel.
* Proficient in speaking and writing local country language and English.
* Effective verbal and written communication skills leading to successful team collaboration
* Strong decision-making. Solution oriented.
* Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
* Experience in developing presentations and presenting key information to stakeholders.
* Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob