- The Country Study Manager will have full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans.
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
- Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
- Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
- May serve as global Country Study Representative (gCSR), as part of global study team.
- Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
- Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
- Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
- Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
The next Country Study Manager should have a Science degree or Pharamcy Qualification with previous project management experience including implementation of risk management plans, management of budgets and resourcing plans. You should also demonstrate excellent clinical development knowledge from an operational standpoint.
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