Experienced clinical research, project management professional with more than 17years of experience in the industry. In-depth knowledge of drug development process (with immunology, inflammatory & oncology focus) and industry practices.
Leading multiple project teams with broad background in overseeing the conduct of the clinical trial (Phase I-IV) globally following elements of the ICH/GCP or GPP in observational and non-interventional studies. Experienced indication lead overseeing study start up, maintenance and termination activities (database lock, CSR), including but not limited to, site identification, feasibilities, ICF negotiations, IRB/EC and global Regulatory Authority submissions, review and approval of essential documents, remote Site initiation visits (SIV), Monitoring Visit (MV), Source data verification (SDV)/ Source Data Review (SDR), drug accountability, site payments, and close out visits. Extensive study and site management experience. Experienced in RBQM, and systems like cluepoints for data analytics. Experienced in leading cross-sectional study team responsible for clinical study delivery as the primary point for contact for leadership. Experienced with vendor management of multiple complex vendors (EDC build and maintenance, IRT/IWRS, central lab, histopath lab, large global CROs as well as drug packaging and distribution vendors). Knowledge of project management processes and tools with multiple direct reports.