As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
Office is based in Bangalore
Responsibilities:
- Medical point of contact and communication for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
- Address medical questions and safety issues across the study from sites and the study team
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Perform ongoing medical review of the operational clinical trial database
- Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Provide input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on project-specific medical and safety-related questions
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Participate in bid defense meetings, Kick off meetings, Investigator’s Meetings (face-to-face or online; international travel required)
- Assist in Pharmacovigilance activities
- Manage ongoing project risks related to medical monitoring
- Participate in Safety Committees management in accordance with the study specific Safety Committees Charter
- Review and sign off clinical documents with respect to medical relevance.
- Medical Doctor degree (MBBS MD)
- Board certification in Infectious Disease
- Prior experience practicing Infectious Disease as a physician or Principal Investigator
- Prior experience in clinical trials at a hospital or industry level would be highly regarded
- Full working proficiency in English
- Proficiency with standard MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
Join our highly dedicated team of clinical research professionals with +250 Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.
