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.