Global Studies Asset Manager (GSAM)

About the role

Roche Pharma Product Development Global Clinical Operations (PDG) is looking for a Global Studies Asset Manager (GSAM) in Basel, Switzerland. The GSAM ensures the consistent and efficient execution of global operations for a group of studies linked to an asset, a disease area or therapeutic area, working with internal teams, partners and vendors. The role sits within the Extended Study Management Team and focuses on Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal and Metabolism.

Key responsibilities

• Coordinate and deliver study management for a group of studies according to ICH-GCP and Roche processes, SOPs and guidelines
• Contribute to study-level documents such as the protocol, trial master plan and pharmacy manual
• Define recruitment expectations with APO, Roche countries and the partner CRO, and maintain a forecast in EFT
• Help develop study management documents and training materials with CRO partners
• Propose and implement new clinical operations approaches with COE, APO and HBS
• Build effective study partnerships with the CRO to avoid duplication and optimise costs and resources
• Develop and oversee KPIs and communicate risks, quality issues and mitigations to the Global Studies Leader
• Maintain inspection readiness and lead third-party vendor selection, setup, oversight and closeout
• Arrange translation and distribution of patient and site-facing materials, and manage supply and shipment of investigational medicinal products
• Give regular feedback to study team members on their performance

Required profile

• Undergraduate degree or equivalent experience, preferably in life sciences, with proven operations experience
• Clinical trial management experience is preferred
• Strong working knowledge of drug development processes and regulations, including ICH/GCP guidelines
• Results-driven, adaptable and able to work in fast-paced, collaborative environments