Job Description
Manager, Trial Delivery Management (TDM) – responsible for the execution of study‑level activities, creation and updating of trial‑specific documents, vendor oversight & delivery, compound training, and other operational functions. The TDM coordinates country and regional operational delivery, aligning feasibility strategy, risk reviews, and local challenges that could impact overall study delivery.
Principal Responsibilities
- Create and update critical trial‑specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation).
- Vendor set‑up and day‑to‑day management of study vendors, including SOW creation and budget oversight.
- Country/regional coordination of trial management activities and oversight (align feasibility strategy with local teams, perform country‑level risk reviews, be aware of all projects across countries).
- Support development of program‑level compound training in collaboration with Clinical/CTL&D Medical writing.
Additional Responsibilities
- Provide input into trial‑level operational strategies.
- Resolve trial‑related issues and mitigate trial‑related risks.
- Participate in process improvement activities at a trial, compound & cross‑DU level, as needed.
- Provide support during Health Authority inspections and identify risks and mitigation plans at the program level for key issues.
- Mentor & support onboarding of new team members, particularly those in Trial Management.
- Foster employee engagement, inclusion, and Credo Behaviors.
Principal Relationships
- Internal: Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Delivery Operations representatives, other GD Functions and Clinical Teams, Procurement representatives.
- External: Vendors.
Education and Experience Requirements
- BS degree or equivalent (preferred Life Sciences such as Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 8 years of related experience in pharmaceutical, biopharmaceutical, biotechnology, or healthcare industries.
- Experience in and knowledge of the pharmaceutical development process, with clinical research operational knowledge across multiple phases (Phase I‑IV).
- 2‑3 years’ experience leading multiple aspects of a global clinical trial.
- Strong leadership, decision‑making, analytical, financial management, and mentoring/coaching skills.
- Excellent project planning/management, communication, and presentation skills.
Preferred Related Industry Experience
- Pharmaceutical, biopharmaceutical, biotechnology.
Preferred Skills
- Analytical reasoning, budgeting, clinical trial management systems (CTMS), compliance management, contract management, execution focus, fact‑based decision making, laboratory operations, mentorship, process improvement, project integration management, research ethics, SOP creation, technical credibility.
Travel
Travel up to 15‑20% of the time, defined by business needs.
Locations
- High Wycombe, Buckinghamshire, United Kingdom – Requisition Number: R-082399
- Beerse, Belgium – Requisition Number: R-082399
- Milano, Italy – Requisition Number: R-082399
- Madrid, Spain – Requisition Number: R-082399
- Warsaw, Poland – Requisition Number: R-082399
- Spring House, PA, United States – Requisition Number: R-082399
- Toronto, Canada – Requisition Number: R-082399
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