- Has the overall responsibility for the study commitments within the country and for the timely delivery of data to the required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
- Leads and optimizes the performance of the Local Study Team(s) at the country level ensuring compliance with the sponsor's Procedural Documents, ICH-GCP, and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure the timely delivery of applications/documents for submissions to the Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in sponsor's clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head)
- Ensures timely preparation of local Master CSA (including site budget) and amendments as required
- Ensures timely preparation of country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with the sponsor's SOPs. Requirements:
- min. 1 year of PM experience
- more than 3 years of CRA experience (Global study experience preferred)
- more than 7 years of Clinical Trial experience
- Vaccine study experience is required
- Good English communication skill is required *Home-based position Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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Country PM - Seoul, 대한민국. - Fortrea
설명
Description
The Opportunity
The Clinical Team Lead (CTL) is responsible and accountable for the driving the delivery of the clinical deliverable, acting as the Clinical Project Management (CPM) role within the Core Team. The successful candidate will have overall responsibility of management, co-ordination and administration of our clinical trials and research projects, including leadership of the team working on the projects delivery. Our team embraces new ideas generation and is open to different perspectives for new processes and encourages people to challenge the status quo.
Fortrea is looking for people who want to step up and bring their positive leadership to foster a high-performing team to greater success.
Responsibilities
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