· Ensure proper study design, execution, and reporting, of the clinical trials under their responsibility, in the established time and quality, and in accordance with GCP. Focus is on pharmacokinetic (PK), bioequivalence and clinical end-point studies / pre-clinical studies.
· Monitoring of the biostudies in accordance with the protocol with the appropriate guidance (EMA, FDA, or others) / as per Sponsor requirement at different phases like Site initiation, during study conduction / dosing, Bioanalysis, Closeout visit.
· Conduction of Remote audits whenever required.
· Design and manage the clinical trial plan / monitoring plan, in accordance with the appropriate guidance (EMA, FDA, or others).
· Preparation / review of monitoring visit reports.
· Qualification / Auditing of CROs and external vendors and control the execution of all contracted activities ensuring that various activities are conducted in accordance with the plans (cost, quality and timelines).
· Review all the necessary documentation before (protocol, etc.), during (Monitoring etc.) and at the end (Report, etc.) of any clinical trial.
· Coordinate all the activities and procedures related with the conduct of clinical trials (Investigational Medication shipment, etc.).
· Collaborate in the interaction with Health Authorities: Scientific Advice and Deficiency Letters.
· Collaborate with Project Management for the appropriate execution of development plans, including, continuous update on timelines and/or budget variations etc.
· Participate in the maintenance of GCP system, through the elaboration and/or review of SOPs, etc.
· Review and sign-off monitoring visit and audit visit reports, as applicable
· Understanding and interpretation of the guidelines for regulatory compliance.
· Any other activities as per management requirement.
· Support to Business development.
Pay: ₹400,000.00 per year
Work Location: In person
