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
