Manager - Medical Science

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:

• 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.

• Preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subject’s 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 timely data extract and participate in data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs).

• 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.