Description:
- Ensure regional/global clinical operations deliverables progress according to agree upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set activities as assigned by the GTL. Support GTL in leading related CRO country & site activities.
- Study Management Team Leader
- Site selection, enrolment, monitor study progress
- Financial planning and tracking
- Document development
- Training and Investigator Meeting
- Cross functional Study Management
- Continuous Quality Focus
- Data Cleaning
- Participate in Global Clinical Development Initiatives as assigned.
Can act as Subject Matter Expert.
Profile: - BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, • Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 6 years clinical trial management experience in the pharmaceutical industry or CRO
- Experience with management and supervision of CROs/vendors is preferred.
- Clinical research operational knowledge, strong project planning/management and effective communication skills.
- Experience and ability in coordinating global or regional teams in a virtual environment. Proven track record in successfully managing various aspects of trials from start-up to database lock.
- Monitoring experience is recommended or other relevant experience should be considered, such as data management or central monitoring.
- Strong knowledge of standard Microsoft applications, willingness to learn new systems.
- Experience with planning tools is an asset.
- Willing to travel internationally up to 20% of time.
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Fecha de publicación: 08/06/2022