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) and study metrics to track the quali...