Title:  Sr. Manager - Clinical Science (Medical Monitor)

• Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meeting.
• Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.
• Review of patient eligibility and approval of patients through Interactive Response Technology (IRT) system
• Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Also, to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs).
• Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents
• Prepare risk assessment plan based on the protocol of clinical study to identify and address the safety and operation related risk specific to study protocol.
• Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints.
• Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee.
• Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, review of study endpoint data review and safety investigations.
• Review of Adverse Events and Severe Adverse Events forms and provide review comments in timely manner.
• Planning publications activities for clinical journal manuscripts, abstracts submission for conferences, and subsequent review of posters/ oral presentations.

• MD (Pharmacology) or other relevant medical qualification
• 2-6 years of relevant experience in the field of Medical Monitoring
• Experience in working in clinical science domain working in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable.

Job location: Sun House, Goregaon East, Mumbai