Job Title

Role and ResponsibilityOverall management of Clinical Research & Medical Affairs department. Ensures timely execution of clinical studies in conformance to GCP, ICH guidelines and regulatory requirements. Review of study related documents such as protocol, IB, CRF Informed consent documents study report, Raw data and CRF compilation etc. Preparation, review, approval of clinical SOPs and their implementation. Screening, selection of volunteers, obtaining informed consent for study participation and study conduct in conformance with protocol. Management and reporting of AE & SAE, treat medical emergencies. Supervising the activities carried out by other clinical team/ staff, facility management. Staff assessment and identification of areas where staff needs higher/ regular training to the staff on GCP /GLP/ SOPs Communication with EC, biostatistician and Sponsor on study updates. Coordinating with Clinical, Bioanalytical, and Pharmacokinetic & Bio-Statistical investigator for timely completion of the studies. Supervision of planning, scheduling, and execution of BA/ BE studies for timely commencement, conduct and conclusion of the projects. Responsibility of investigational drug products including receipt, dispensing and accountability.Requirements:Educational qualification MBBS, MD pharmacology or pathologyPreferred 0-2 + years of experience as investigatorGood knowledge on Clinical research, specifically in Bioequivalence (BE) studies.Excellent understanding of regulatory requirements and market dynamics in these regions.Proven ability to generate and close business deals in the pharmaceutical/clinical research sector.Strong communication, negotiation, and presentation skills.Ability to travel internationally as needed.