Manager - Medical Science

Sun Pharma; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharmaceutical Industries is seeking a Medical Monitor to oversee clinical trial activities in Mumbai, ensuring proper eligibility assessment, endpoints review and safety investigations. The role emphasizes collaboration with clinicians and the data team to maintain trial integrity.

The candidate should hold MBBS with MD (Pharmacology) and have 1–2 years of experience in clinical science or as a medical monitor, contributing to protocol clarity, regulatory interactions, and medical writing.

Qualifications

• MBBS with MD (Pharmacology) required.
• 1–2 years of relevant clinical science experience or as medical monitor.
• Experience in clinical trials/medical development plans desirable.

Responsibilities

• Medical monitoring including eligibility assessment, endpoint review, and safety investigations.
• Prepare synopsis, protocol, CSR and present to SEC regulatory meetings.
• Collaborate with clinicians and KOLs on trial design, endpoints and comparators.
• Review patient eligibility and approvals via IRT systems.
• Coordinate with data management for timely data extraction and database lock of TLFS.

Skills

Medical monitoring

Clinical trial design

Regulatory interactions

Education

MBBS + MD (Pharmacology)

Job description

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.
• Review of AE and SAEs forms and provide review comments in timely manner
• Medical writing of scientific documents
• 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

Job Requirements

Educational Qualification

MBBS +MD (Pharmacology)

Experience

1 -2 years previous work experience.

Skills required include

• MD (Pharmacology) or other relevant medical qualification with 1-2 years of relevant experience or fresher.
• 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.

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).