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Regional Clinical Study Manager
BeOne MedicinesRegional Clinical Study Manager overseeing oncology clinical studies ensuring quality and compliance within timelines. Leading a regional team and collaborating with stakeholders to achieve study goals.
About the role
Key responsibilities & impact- Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
- Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
- Ensures alignment of regional deliverables with overall study goals
- Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
- Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs
Requirements
What you’ll need- Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred
- 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
- Proven experience in clinical research including relevant experience as team lead in clinical functions
- Experience as CRA is preferred
- Computer Skills: MS Office, Project Planning Applications
Benefits
Comp & perks- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant!)
- In-house and external learning and development opportunities
- Fantastic benefits program
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchstudy managementregulatory submissionproject planningteam leadershipinspection readinessbudget managementfeasibility assessmentclinical study closeout
Soft Skills
problem resolutioncollaborationcommunicationorganizational skillsstakeholder management