Prepare, review and approve clinical trial/ BA - BE studies documents.
Protocol training, execute discussions with CRAs and PM.
Medical support to the study team during site evaluation, selection, and EC approvals, study initiation, conduct and closeout.
Medical Support for Regulatory Approvals in NDAC Meetings.
Review and approve DMP, DVG & project related CDM documents
Preparation of Standard Operating Procedures.
Presentation/Publication of the results of clinical trials in national/international conferences and journals.
CRO evaluation, selection for outsourcing clinical research projects.
Preparing and implementing CAPA.
Real Time Management of SAEs.
Well versed with basic regulatory guidance like ICH-E6, ICH-E3, Schedule Y etc
Basic understanding of principles of pharmacokinetics and safety evaluation in clinical trials
Good network in academia Regular interaction in Symposiums, CMEs, Academia, KOLs, PGI, AIIMs etc.
Able to convert Science into Business by pursuing Academia and Doctor fraternity
Should have done Patient Based Biostudies (Volunteer).