Global Studies Asset Manager, Clinical Operations Lead

Roche; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche in Basel, Switzerland seeks a Global Studies Asset Manager (GSAM) within Pharma Product Development Global Clinical Operations (PDG). The role ensures consistent global operations for a group of studies, collaborating with internal teams and partner CROs to deliver timely and compliant study execution.

You will lead study management activities, contribute to essential study documents, forecast recruitment, and drive KPI-based performance.

Qualifikationen

• Undergraduate degree in life sciences or equivalent with relevant operations experience.
• Experience with drug development processes and regulations (ICH/GCP).
• Growth mindset, proactive and collaborative in fast-paced settings.

Aufgaben

• Coordinate and deliver study management for a group of studies within an asset portfolio following ICH-GCP and Roche SOPs.
• Contribute to essential study-level documents (e.g., protocol, TMP, Pharmacy manual).
• Develop recruitment forecasts with APO, Roche countries and CRO partners; maintain forecasts in EFT or equivalent systems.
• Collaborate with CRO partners to develop and maintain study materials (Pharmacy manual, IMP management documents).
• Drive operational innovation in partnerships with COE, APO and HBS to meet industry best practices.
• Foster effective study partnerships with TA-aligned CROs to optimize expertise and resource use.
• Develop and monitor KPIs for areas of responsibility and communicate risks and mitigations.
• Maintain inspection readiness for components under responsibility; oversee vendor selection and oversight.
• Produce, translate, and distribute patient and site-facing materials; manage IMP supply and shipment.
• Provide feedback to team members to support development and a high-performing organization.

Kenntnisse

Operations experience

Drug development knowledge

ICH/GCP familiarity

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

Roche in Basel, Switzerland seeks a Global Studies Asset Manager (GSAM) within Pharma Product Development Global Clinical Operations (PDG). The role ensures consistent global operations for a group of studies, collaborating with internal teams and partner CROs to deliver timely and compliant study execution.

You will lead study management activities, contribute to essential study documents, forecast recruitment, and drive KPI-based performance.