Job Description
Job Descriptions
- Ensure appropriate monitoring oversight plans are in place and reflect adequate adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
- Lead in study planning to ensure appropriate study timeline, budget and resource are in place.
- Obtain appropriate and sufficient resources as required for the studies.
- Lead the clinical core team in executing of study tasks in according to the study plan.
- Lead the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with key stakeholders within the Study Management Team(SMT).
- Oversee CRO in executing clinical operations related activities from study setup, sites startup, enrollment, study maintenance, interim/final analyses, study closeout, clinical study reports, annual reports, and other clinical documents.
- Monitor Key Performance Indicators (KPIs) an...