Medical Monitor (Infectious Disease)

As part of PSIs 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

Performs 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

Provides 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

Manages ongoing project risks related to medical monitoring

Participates 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

Board certification in Internal Medicine

Prior experience as a practicing Infectious Disease

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

Full time