Descrizione:
Experteer Overview
As Clinical Study Manager you will lead end-to-end operational delivery of complex trials within a global, cross-functional team. You drive RBQM-based quality, patient safety, and regulatory compliance to ensure on-time, within-budget study outcomes with inspection readiness. You collaborate across internal functions and external partners to translate global protocols into effective execution. This role offers meaningful impact through shaping trial performance and ensuring high data integrity in a fast-moving development environment.
Retribuzione / Benefits
- Lead planning and execution of complex interventional trials from start-up to close-out with RBQM throughout
- Ensure alignment with global study strategy, timelines, and milestones defined by the Lead Clinical Study Manager
- Act as an accountable member of the Clinical Trial Team, contributing to decisions and issue resolution
- Provide proactive risk-based oversight, identify trends and mitigate quality signals
- Champion quality by design with emphasis on patient safety and data integrity
- Maintain TMF completeness and inspection readiness across the study lifecycle
- Support audit and inspection preparedness and follow-up activities
- Serve as primary contact for CROs and external vendors, managing quality and contractual delivery
- Monitor vendor performance via KPIs and RBQM outputs
- Coordinate activities across Data Management, Biostatistics, Drug Supply, Pharmacovigilance, Regulatory Affairs, and others
- Contribute to the preparation/review of key documents (protocol sections, ICFs, CSRs) and support data review/cleaning for timely database lock
- Assist in regulatory document preparation (e.g., IB, ASRs) and results posting in public databases
Responsabilità
- 4–6 years of clinical trial experience in pharma, biotech, or CRO environments
- Hands‑on experience managing complex global interventional trials
- Experience across site roles (e.g., CRA) and clinical study management
- Oversight of CROs and external vendors with quality and performance accountability
- Strong experience in study start-up, recruitment oversight, and close-out
- Knowledge of regulatory/operational requirements and inspection readiness
- Ability to manage multiple priorities in a complex, matrix environment
Requisiti fondamentali #J-18808-Ljbffr