Sun Pharma—Sr. Manager - Clinical Science

Job description

Description: Job Title: Senior Manager - Medical Science Business Unit: MACR Location: Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” YOUR TASKS AND RESPONSIBILITIES: - Lead the clinical trial medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subject’s expert committee (SEC) regulatory meeting. - Planning publications activities for clinical journal manuscripts, clinical journal abstracts, and study article. Identify additional clinical data analysis in collaboration with statistics team and subsequently submission and present the data in scientific forums - 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 AE and SAEs forms and provide review comments in timely manner. Job Requirements Educational Qualification MBBS +MD (Pharmacology) Experience 5 -8 years previous work experience. Skills required include: - MD (Pharmacology) or other relevant medical qualification with 5-8 years of relevant experience. - 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. Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).