Clinical Science Lead

18 hours ago

Mumbai, India Maxis Clinical Sciences Full time

Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.

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

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 AE and SAEs 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

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