Job summary
This senior role involves leading and delivering clinical studies within a specified region. The manager oversees regional operations teams and external partners to ensure study goals are met with high-quality standards, compliance, and within timeline and budget constraints. The position requires collaboration with multiple stakeholders, oversight of study feasibility, regulatory submissions, monitoring, and preparation for audits and inspections.
Location and work setup
- Location
- Oslo
- Work setup
- Remote
Salary
EUR 80000.00–100000.00 year
Responsibilities
Lead the regional clinical operations team and external vendors to ensure smooth study execution. Manage study timelines from feasibility through closeout. Drive trial feasibility and site selection in collaboration with stakeholders. Oversee regulatory document adaptations and submissions in the region. Ensure data collection, site monitoring, and Trial Master File maintenance comply with protocols and regulations. Monitor quality and inspection readiness. Manage regional budgets, resources, and vendor relationships. Support and mentor junior team members, providing performance feedback.
Qualifications
Bachelor's degree in scientific or healthcare field required; advanced degrees preferred. Minimum seven years of clinical research experience, preferably within biotech, pharma, or CRO settings. Proven leadership experience in clinical operations. Prior experience as a Clinical Research Associate is advantageous. Proficient with MS Office and project planning tools. Willingness to travel as needed.