Senior Project Manager, Clinical Operations
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The Senior Project Manager will act as functional project lead reporting to the Associate Vice President of Clinical Operations. Responsible for the planning, execution and conduct of one or more commercially sponsored clinical trials as well as oversight of any investigator-initiated trials being conducted. Trials are to be executed on time, within budget, compliant with all relevant regulatory and ethical requirements, and be of the highest quality to support submission to relevant authorities for drug approval.
Key Responsibilities:
1. Delivery on all clinical operational aspects of assigned clinical trials ensuring compliance with all applicable laws and regulations, company Standard Operating Procedures (SOPs), study contracts, budgets and timelines from start up through to clinical study report.
2. Primary interaction with internal and external cross functional teams and key stakeholders, ensuring clinical trial and department objectives are met.
3. Development of Request for Proposals (RFPs) and scope of services for outsourced clinical activities.
4. The assessment and selection of Contract Research Organisations (CROs)/other vendors, seeking input from other internal functional updates and ensuring qualification of vendors in accordance with company SOPs.
5. Oversight of CROs/vendors by serving as primary contact, problem resolution and defining Key Performance Metrics.
6. Tracking of project deliverables using appropriate tools incorporating risk management.
7. Prepare reports for management on program status and issues.
8. Interact and establish relationships with clinical trial investigators, key opinion leaders, DSMBs, Scientific Advisory Board members and development partners.
9. Writing and coordinating review of key documents, including but not limited to protocols, subject information sheets/informed consents, case report forms, study plans and clinical study reports.
10. Coordination of audits as required, responding to CAPAs and ensuring trials are always Inspection Ready.
11. Involvement in general Clinical Operations department initiatives/activities including reviewing SOPs and input into process improvements.
12. Contribute to other Clinical Operations and R&D Department/company activities and initiatives as required.
Key Requirements:
1. At least 10-15 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 5 years of in-depth experience of CRO oversight in Phase III trials.
2. Experience in multiple Therapeutic Areas (Rare disease or Oncology preferred but not essential).
3. Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing study activities, from startup through final study report.
4. Strong leadership competencies and influencing skills.
5. Strong interpersonal and communication skills (written and verbal) for bridging across diverse, cross functional, multi-national, geographically dispersed teams.
6. Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
Role Requirements:
1. Permanent, full time position.
2. UK hybrid / remote, with a requirement to travel to office in Cardiff, Wales every 4-6 weeks and travel domestically/Internationally as necessary for the clinical program/s.
No recruitment agencies.
Seniority level
Mid-Senior level
Employment type
Full-time
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