- Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. (Accountable for study deliverables and drives key decisions within set country)
- Plan, manage, and maintain oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
- Support country-level operational planning and accountable for site selection within assigned country(ies)
- Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
- Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
- Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
- Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
- Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process
- Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:
- Monitor and review country and study trends Review Monitoring Visit Reports
- Identify and facilitate resolution of cross-functional study-specific issues
- Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships
REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a healthcare or other scientific discipline
- Minimum 1-2 years' experience of leading local/regional or global teams
- Minimum 1-2 years' clinical trial project management experience
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).
REQUIRED KNOWLEDGE
- Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc.
- Clinical trial processes and operations
- Extensive knowledge of ICH/GCP regulations and guidelines
- Project and Program management including oversight of study deliverable, budgets and timelines
- Time, cost and quality metrics, Key performance indicators (KPIs)
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at -
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Clinical Trial Manager - Berkshire, United Kingdom - IQVIA
Description
IQVIA's cFSP team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward.
Great opportunity to shape local component of global study (UK remit / 2 studies across 8-10 sites / phase I-III). Sponsor dedicated to one of the world's largest pharmaceutical companies. Fully remote with minimal travel.
RESPONSIBILITIES
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