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Study Manager
As a contract Study Manager at Roche, you will join the Pharma Research and Early Development (pRED) Clinical Operations team. You will be responsible for delivering study management and clinical operations activities for early-phase clinical studies, working within a cross-functional team to ensure study quality, integrity, and operational excellence.
Responsibilities
- Contribute to protocol design, feasibility, country selection, and patient-centricity.
- Develop and maintain study systems and documentation, including informed consent forms and Trial Master Files.
- Provide country oversight to ensure timely study start-up and recruitment.
- Manage vendor performance and third-party relationships to ensure adherence to ICH/GCP and internal standards.
- Oversee the planning and supply of clinical materials.
- Manage study-related risks and compliance issues.
- Drive operational improvements and consistency across clinical studies.
Requirements
- University degree or equivalent experience, preferably in life sciences.
- Proven performance as a Study Manager or equivalent in the pharmaceutical or healthcare industry.
- Strong knowledge of the drug development process, including ICH and GCP guidelines.
- Growth mindset with the ability to thrive in fast-paced, ambiguous, and collaborative environments.
- Self-starter with a passion for innovation and delivering successful outcomes.
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