Sr. Manager - Clinical Science

Sun Pharma; Mumbai; In loco; INR 1.800.000 - 3.500.000; Tempo pieno

Descrizione del lavoro

Sun Pharma is seeking a medical professional to lead clinical trial medical science activities, develop study concepts, and present proposals to regulatory bodies. You will collaborate with clinicians, statisticians, and CRO partners to ensure data quality and timely study milestones.

The role requires 5–8 years of clinical trial experience, MBBS/MD (Pharmacology), and a proven track record as a medical monitor or development-planning expert across therapies.

Competenze

• MBBS and MD (Pharmacology) or equivalent medical qualification.
• 5–8 years of relevant clinical trial experience.
• Experience as medical monitor for clinical trials or medical expert for development plans across therapies is desirable.

Mansioni

• Lead clinical trial medical science activities: synopsis, protocol, CSR preparation, SEC presentations.
• Plan publications for journals and abstracts; coordinate data analysis with statistics team.
• Collaborate with clinicians and KOLs to obtain feedback on trial design, endpoints, and synopsis.
• Review patient eligibility and approvals via IRT systems.
• Coordinate with data management on data cleaning, coding plans, and database lock timelines.
• Engage with biostatisticians early to discuss sample size, SAP, and TFLs.
• Prepare risk assessment plans based on protocol and study endpoints.
• Train study team on protocol relevance and critical activities.
• Interact with investigators to resolve protocol queries from sites and Ethics Committee.
• Oversee safety monitoring: eligibility, endpoint data review, and SAE reviews.
• Review AE/SAE forms and provide timely comments.

Conoscenze

Medical monitoring

Clinical trial design

Formazione

MBBS

MD (Pharmacology)

Descrizione del lavoro

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).