Sr. Manager, Trial Delivery Leader
Location: High Wycombe, Buckinghamshire, United Kingdom
Responsibilities
- Lead the Cross Functional Trial Team (CFTT) to influence and execute the operational plan and end‑to‑end trial execution.
- Accountable for overall trial delivery, budget, timelines, quality, and milestones (including support for DBL/CSR/TLR planning, scope activities, protocol deviation definition, and resolution pathways).
- Proactively ensure that trial deliverables and milestones are met.
- Identify risks and ensure mitigation and contingencies are initiated and followed through.
- Ensure trial is operationalized in compliance with global health authority regulations, guidelines, and internal operating procedures and processes.
- Identify risks in study conduct, develop mitigation plans, and escalade concerns to the CT or CDT.
- Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
- Maintain a constant state of inspection‑readiness, collaborating with R&D Quality to ensure quality oversight.
- Participate in process improvement activities at trial, compound, and cross‑DU levels as needed.
Additional Responsibilities
- Lead and ensure inspection readiness for the program through risk identification and readiness review.
- Provide leadership during Health Authority inspections and identify risks and mitigation plans at the program level for key issues.
- Mentor and support onboarding of new team members, particularly those in Trial Management.
- Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications and Requirements
Education: Bachelor’s degree required. Preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Required
- Minimum 8 years in Pharmaceutical, Healthcare, or related industries.
- Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
- Experience and knowledge of the pharmaceutical development process.
- Clinical research operational knowledge and experience across multiple study phases (Phase I‑IV); ability to manage all aspects of clinical trial execution.
- Excellent leadership skills with a proven ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi‑functional, matrixed, and global environments.
- Strong decision‑making, analytical, and financial management skills.
- Ability to operate and execute with limited supervision.
- Experience mentoring or coaching others.
- Strong project planning, management, communication, and presentation skills.
- Travel up to 15‑20% of the time, as defined by business needs.
Preferred Skills
- Budgeting
- Clinical Trial Designs
- Clinical Trials
- Compliance Management
- Consulting
- Contract Management
- Execution Focus
- Fact‑Based Decision Making
- Give Feedback
- Industry Analysis
- Laboratory Operations
- Organizing
- Process Improvements
- Project Integration Management
- Research and Development
- Research Ethics
- Technical Credibility
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