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The Principal Investigator will oversee clinical research and medical affairs activities in Bengaluru, Karnataka. Responsibilities include the management of clinical research, execution of clinical studies aligning with GCP and ICH guidelines, reviewing study-related documents, and coordinating with investigators for the timely completion of studies.
Job Responsibility:
Overall management of Clinical Research & Medical Affairs department
Ensures timely execution of clinical studies in conformance to GCP, ICH guidelines & regulatory requirements
Review of study related documents such as protocol, IB, CRF, informed consent document, study report, Raw Data and CRF compilation
Coordinating with Clinical, Bioanalytical and Pharmacokinetic and BioStatistical 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 project
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