- Provide inputs on protocol preparation from clinical perspective, based on therapeutic area & study phase
- Prepare and Participate in Subject Expert Committee (SEC) Meetings & similar meetings with regulatory agency such as CDSCO
- Responsible for Sponsor facing clinician role, for all clinical decisions, during pre-study, study execution, post study activities till clinical study report
- Provide protocol and therapeutic area training to study teams (both internal and external).
- Provide response to study investigator/Ethics committee queries.
- Prepare study specific medical monitoring plan
- Review of Protocol deviations, on real time basis
- Review of Clinical study report / Site Monitoring Plan etc
- Review study subject reports (like Medical history, lab reports, ECG report, cytology, 2D- ECHO, CT, Bone Scan reports, any clinical 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.
- Develop & Review protocol amendments (if required) and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan
- Responsible for review of Adverse event and Serious adverse event data in the clinical trial for its completeness and accuracy
- Responsible for review of Serious adverse event (SAE) forms received from trial sites
- To communicate various safety related aspects with the stake holders i.e., Study team to site, and various regulatory agencies and Sponsor team
- Responsible for preparation of Serious adverse event (SAE) reporting Data Elements for Reporting Serious Adverse Events Occurring in A Clinical Trial
- 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, listing review
- Performing the Case Analysis and Peer Review (Quality check)
- Perform medical review (including verifying the coding & labeling reviewing narratives causality statement medical aspect of follow-up request)
- Validate follow-up request and perform medical assessment of the case for the Category I and II cases
- Prioritize workloads to ensure expedited cases are processed within defined timelines
- Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP
- Approval and the locking of Category I cases
- Responsible for the timely reception of an individual case on a daily basis
- Responsible for registration in e-log book and for the duplicate search process
- Ensure quality and timely creation and closure of PV query as per SOP
- Ensure the filing of PV dossier and documents as per the SOP
Essential
MBBS, MD-Pharmacology, Fresher
