Clinical Study Manager
About The Position
Job Overview 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 Essential Functions Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study. Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required Manages regional study budgets Monitors regional resource utilization over study lifecycle and liaises with functional managers as needed Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs off monitoring reports
Requirements
- Bachelor's Degree required
- 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 with site management and engagement
Nice To Haves
- Experience as CRA is preferred
- Recent (within 1-2 years) oncology experience as a study manager.
- Focused in solid tumor or hematological oncology studies.
Responsibilities
- 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 the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study.
- Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
- Manages regional study budgets
- Monitors regional resource utilization over study lifecycle and liaises with functional managers as needed
- Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
- Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
- Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
- Collaborates closely with CRAs in the region to ensure proper study execution at the sites.
- Reviews and signs off monitoring reports
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
