Manager/ Assistant Manager- Clinical Research Required @ Panacea Biotech - Just 3 Yrs Exp reuired, "D4"

Role: Assistant Manager Clinical Research Education: Medicine/ Pharmacy / Life Sciences Experience: From 3-5  Years in CR industry Salary: As per industry norms Location: Delhi Job Description Desired ProfileTo review and approve clinical trial/ BA - BE studies documents To provide protocol training and execute discussions with CRAs and project manager To provide medical support to the study team during site evaluation, selection, regulatory and EC approvals, study initiation, conduct and closeout To prepare study report, coordinating with PM to obtain investigator’s / opinion/approval and finalization To be a sponsor’s medical monitor for in-house as well as outsourced clinical trials/BA – BE studies To provide literature support for clinical trials, marketed products and for regulatory submissions To do medical writing for regulatory submissions for products: SmPC, Package inserts, Patient information leaflet and Technical reports Active involvement in new product development program and in project review meetings for Panacea Biotec products To prepare and review Standard Operating Procedures To ensure presentation/publication of the results of clinical trials/ BA – BE studies in national/international conferences and journals To coordinate with project manager to provide preventive and corrective action plan of QA audit To assist AGM and senior management in CRO evaluation, selection for outsourcing clinical trial/BA – BE studies To coordinate with partner CROs for Protocol and other Clinical trial document finalization, and providing medical support during Site evaluation, selection, regulatory and EC approvals, study initiation, conduct and closeout for outsourced clinical trials/BA – BE studies. To Apply here