In this role, you will lead the Study Management Team to coordinate global clinical operations for both in‑house and outsourced trials. You ensure timely delivery of study milestones, oversee country/site activities, and maintain inspection readiness across GCDO. You partner with the Global Trial Lead and act as a primary contact for country/regional teams and CROs. You shape trial planning, risk mitigation, and quality oversight, contributing to the sponsor’s regulatory and data integrity goals. This is a chance to drive global collaboration and process improvement in a complex, fast‑paced environment.
Responsibilities
- Lead the Study Management Team and provide status updates to trial members
- Ensure real‑time trial status reporting and documentation of progress
- Maintain inspection readiness and compliance with SOPs, GCP, and regulations
- Act as primary contact for country and regional staff and for local GCDO teams
- Coordinate central activities from planning to close‑out with the Global Trial Lead
- Escalate issues and drive CAPA resolution as CAPA owner or contributor
- Support site selection, feasibility, enrollment planning, and vendor oversight including budgets
- Develop trial‑specific documents and training materials; support Investigator Meetings
Qualifications
- BS degree or equivalent in Life Sciences
- 6–8 years of clinical trial management experience in pharma or CRO
- Strong knowledge of ICH‑GCP, local laws and regulations
- Proven leadership xysqume to drive SMT and manage stakeholders
- Experience coordinating global/regional teams in a virtual environment
- Proven ability to plan, manage risk, and drive projects to database lock and close‑out
- Strong IT skills, CTMS, TMF, and willingness to learn new systems
- Travel flexibility and proficiency in local language and English
- Excellent communication and decision‑making abilities
- Experience with budgeting, vendor management, and submission support
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