Medical Monitor

Qualification: MBBS with any PG or DNB or Diploma.

Experience: 2 - 4 Years’ Experience in Clinical Research Filed.

·Provide protocol and therapeutic area training to study teams (both internal and external).

·Provide response to PI/site/EC queries.

·Prepare medical monitoring plan

·Review of PDs

·CSR/SMP/SAP review

·Review study subject reports (like lab reports, ECG report, cytology, 2D- ECHO, CT, Bone Scan reports, , any assessments etc, as applicable) for eligibility  in coordination with Project Manager/Designee.

·SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly.

·Review and develop amendments (if required) to Protocol and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan.

·Liaison with investigators and sponsor medical monitor for any medical queries.

·Responsible for review of AE and SAE data in the clinical trial for its completeness and accuracy

·Responsible for review of SAE forms received from Sites.

·To communicate various safety related aspects with the stake holders i.e., Study team to site, and various regulatory agencies and Sponsor’s team.

·Responsible for preparation of SAE reporting “Data Elements for Reporting Serious Adverse Events Occurring in A Clinical Trial or Bioavailability or Bioequivalence Study”.

·Responsible for coordination with internal Regulatory and operation team for completion of SAE forms, reconciliation and tracker compilation.

·Responsible for ensuring electronic reporting of SAEs to DCGI, Chairman of Ethics Committees and Head of Institutions within stipulated timelines.

·Responsible for Preparation of individual case narratives.

·Responsible for preparation of the CSR.

·AE, Concomitant Medication, Medical History, Vital signs, Physical examination, I/E listing review.

·Review the blinded study data on regular periodic basis