Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
B.Sc. (Biochemistry / Chemistry / Botany / Zoology / Life Sciences / Biotechnology) with 50% marks and Degree / Diploma in Medical Laboratory Technology (DMLT) from Government recognized Institute.
Msc in Life Science, M.Pharm with Post Graduate Diploma in Clinical research is Mandatory. Pharm.D. One years Experience in clinical research is Mandatory.
Proven ability to follow instructions and guidelines, work independently, and take initiative. Excellent attention to detail and accuracy in maintaining high-quality standards.
Post graduation in Science (M.Pharma, Life Science Biotech, Zoology, Botany) with PG diploma in Clinical Research. Candidate must have experience of 3 or more years in monitoring or handling of interventional clinical trials (RCTs) (Preferable in Oncology).
Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.