Responsibilities:
- End-to-end project management and performance for assigned protocols/studies in a country (and possibly across a cluster).
- Main POC between Country Operations and the clinical trial team (CTT); plan, drive, track deliverables/timelines/results from feasibility through close-out.
- Ensure compliance with ICH/GCP, country regulations, internal policies/quality standards, and internal/external adverse event reporting.
- Review monitoring visit reports; escalate performance issues/training needs; perform quality control visits as required.
- Lead local study teams: train local roles on protocol, support CRAs as protocol expert, coordinate local country activities (CTC/CRAs/COM).
- Create/execute local risk management; ensure compliance with CTMS/eTMF and key systems.
- Collaborate with outsourcing vendors/investigators/partners; represent the company with investigators; support local business needs (if delegated: contracts/budgets).
- Collaborate with internal HQ/regional functions (e.g., EU Clinical Development, Pharmacovigilance, Global Medical Affairs).
Core competency expectations:
- Project/site management; strong organizational/decision-making; understanding of local regulations; clinical/scientific knowledge; trial planning/metrics; resource and quality management; strong written/verbal communication (English + local language); strategic thinking; remote/virtual collaboration.
Behavioral expectations:
- Leadership and alignment; early problem identification and mitigation/conflict resolution; negotiation; relationship building.
Required:
- 5+ years clinical research experience; Bachelorβs in science (or comparable).