Manager / Assistant Manager- Medical Affairs

Job Description

Conducting the feasibility for the clinical trials as per the requirements of the sponsor.

Prepare and review study related documents like Protocol Synopsis, Study Protocols, Investigators Brochure, Informed consent forms, Clinical study reports, Patient diaries, Case Record Form etc.

Liaises with the study team, Sponsor and the key opinion leaders in therapeutic areas to finalize the study related documents.

Medical Monitoring at site level which comprises of review of Site Investigator File, Safety and SAE reporting documents, Laboratory documents and reports, X-ray and ECG reports.

To ensure that safety information received from the site/sponsor is processed consistently, accurately in a timely manner and in compliance with GCP/protocol/agreed SOPs/Schedule Y and reported to DGCI and appropriate personnel

Perform the role of the Medical lead in the various clinical development programs and clinical trials being conducted by the department.

Lead or assist in team communications/interactions with various internal stakeholders like the Clinical operations, Biostatistics, Quality assurance, Finance department etc and external stakeholders like the regulatory agencies, study sponsors etc.