Medical Monitor - Clinical Development

We are seeking a Medical Monitor to provide medical oversight for ongoing clinical trials, including review of subject eligibility and data, interactions with investigators, site visits, and medical guidance to investigators, CRO team and Clinical Project Managers.

The job holder shall be responsible for delivering protocol and disease-specific medical training to Clinical Operations teams while managing day to day medical operations activity, review of EDC data for appropriateness and adequacy, review of protocol deviations

The Medical Monitor shall support study start up activities including EDC set up and its alignment with the protocol requirements and drafting /reviewing of other study documents and ensure GCP compliance during the conduct of clinical trials while also contributing to preparation of clinical study protocols, medical oversight documents, safety monitoring plans and clinical development plans.

Overall, the Medical Monitor shall also maintain accountability for scientific and medical review of study data and support timely issue resolution.

KEY ACCOUNTABILITIES

1. Medical monitoring and oversight of assigned clinical studies.

2. Timely management of investigator and Clinical Operations medical queries.

3. Contribute to protocol and medical document development

4. Medical review of clinical data, trends and safety signals, conduct of medical oversight meetings and participation in clinical data review process

5. Management of subject eligibility and subject's progress in the study

EDUCATION & EXPERIENCE

• MBBS, MD with minimum 2 years of industry experience

• Additional Qualifications: Additional certification or relevant postgraduate qualification preferred.