Manager, Trial Delivery Management

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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

• High Wycombe / Maidenhead, United Kingdom
• Beerse, Belgium
• Breda, Netherlands
• Madrid, Spain
• Spring House/ Titusville / Raritan / Horsham, United States

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom
- Requisition Number: R-086693

Belgium, Spain, Netherlands
- Requisition Number: R-094113

United States
- Requisition Number: R-094118

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Manager, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The Manager TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

• Creating and updating critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
• Vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
• Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
• Supporting development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.
• Providing input into trial level operational strategies.
• Resolve trial-related issues and mitigate trial-related risks.
• Participating in process improvement activities at a trial, compound & cross-DU level, as needed.
• Providing support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentoring & supporting onboarding of new team members, particularly those in Trial Management.
• Fostering employee engagement, inclusion, and Credo Behaviors.

Internal:
Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement

Are you ready to join our team? Then please read further!

• BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology,
• Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries!
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a…