Global Studies Asset Manager (GSAM)

Contract length: 6 months

Pay rate: Up to £500.00 per day (via umbrella)

Location: Welwyn Garden City (hybrid working, 2-3 days on site)

Position Overview

We are determined to transform drug development and deliver transformative medicines that address diseases with the highest societal burden. We are looking for a Global Studies Asset Manager (GSAM) to lead and drive the operational study management delivery of one (or more) of our molecule assets. This position holds responsibility for clinical operations management and execution across primary disease focus areas including Oncology, Hematology, Neurology, Immunology, Ophthalmology, and Cardiovascular, Renal, and Metabolism (CVRM).

The GSAM is responsible for the consistent and efficient execution of global operations for a group of studies related to an asset, or within a Disease Area (DA) or Therapeutic Area (TA). Working closely with internal teams, partner operations, cross-functional experts, and vendor partners, the GSAM serves as a vital member of the Extended Study Management Team (SMT) to ensure smooth operational delivery.

Key Responsibilities

• Study Management & Delivery: Coordinate and deliver the study management aspects of a group of studies within an asset's portfolio following ICH-GCP and company processes to ensure clinical studies progress as planned.
• Document & Plan Development: Provide input into essential study-level documents (e.g., study protocols, TMPs, Pharmacy manuals) and study plans/training materials (e.g., IMP management) in collaboration with CRO partners.
• Recruitment & Forecasting: Develop study recruitment expectations in partnership with internal analytics teams, country operations, and partner CROs, maintaining forecasts using appropriate tracking systems.
• Innovation & Best Practices: Drive innovation in clinical operations by implementing new approaches to meet and exceed industry best practices.
• CRO & Vendor Management:
  • Build strong, trusting relationships with TA-aligned CRO partner study management teams.
  • Lead 3rd-party vendor selection, setup, oversight, and closeout to ensure delivery to contract requirements.
  • Support the resolution and escalation of study-level vendor performance issues.
• Performance & Quality Oversight:
  • Develop and oversee key performance indicators (KPIs—quality and operational) using company tracking systems.
  • Proactively communicate risks to timelines or quality, along with proposed mitigations, to the Global Studies Leader.
  • Maintain inspection readiness for relevant operational components.
• Operational Execution: Produce, arrange translation for, and distribute patient/site-facing support materials; manage supply and shipment of IMP; and obtain/distribute clinical trial insurance.
• Team Development: Regularly seek and provide feedback to study team members on performance to support professional development and foster a High-Performing Organization.