Global Studies Asset Manager (GSAM)

We are seeking a Global Studies Asset Manager to coordinate and deliver global clinical operations for a portfolio of studies, ensuring efficient and consistent execution. The role involves close collaboration with internal teams and partners, requiring experience in drug development processes and operations.

• Coordinate and deliver the study management aspects of a group of studies within an asset’s portfolio following ICH-GCP and Roche processes in accordance with SOPs and guidelines to ensure the clinical study progresses as planned.
• Provide input into the development of essential study level documents (e.g. study protocol, TMP, Pharmacy manual).
• Develop a study's recruitment expectations in partnership with APO, Roche countries and the partner CRO, and develop and maintain a forecast using the appropriate systems (EFT).
• Develop and/or maintain or provide input in collaboration with CRO partners, study management essential documents (e.g. Pharmacy manual, relevant study plans, relevant training materials such as IMP management).
• Drive innovation in clinical operations by contributing to the implementation of new approaches in partnership with COE, APO and HBS to deliver outcomes that meet and exceed industry best practices.
• Build and role model effective study partnership behaviors and mindsets with your TA aligned CRO partner to maximize the expertise of the CRO and internal colleagues, minimizing duplication of work and ensuring cost and resource efficiency for studies in responsibility.
• Develop and oversee key performance indicators (KPIs, quality and operational) for areas of responsibility by using company tracking systems and proactively communicating any risks to timelines and/or quality, or identified quality issues, along with proposed mitigations to your Global Studies Leader.
• Maintain inspection readiness of the relevant components in scope of responsibility.
• Lead 3rd party vendor selection, setup, oversight, and closeout to ensure delivery to contract (in line with relevant iCOP strategies and study level needs).
• Produce, arrange translation, and distribute patient and site facing support materials.
• Manage supply and shipment of IMP.
• Regularly seek and provide feedback to study team members on their individual performance to support their professional development and contribute to the achievement of a High Performing Organization.