Clinical Trial Job at SUN Pharma, Mumbai
Looking for a leadership role in Clinical Science with one of India’s top pharmaceutical companies? Sun Pharma Laboratories Ltd is inviting applications for the position of Senior Manager – Clinical Science (Medical Science) at its Corporate Office in Mumbai. This Clinical Trial Job in Mumbai is ideal for MBBS + MD (Pharmacology) professionals with clinical research and medical monitoring experience. If you are passionate about leading clinical trials, collaborating with cross-functional teams, and contributing to global drug development, this role at SUN Pharma Careers offers an excellent career opportunity.
About the Company:
Sun Pharma Laboratories Ltd is India’s largest pharmaceutical company and one of the world’s leading specialty generic pharmaceutical organizations. Operating across more than 100 countries, Sun Pharma is committed to delivering high-quality, affordable medicines through continuous innovation and scientific excellence. The company promotes a culture of learning, collaboration, and leadership, empowering employees to “Create Your Own Sunshine” while making a meaningful impact on global healthcare.
Job Details:
- Job Title: Senior Manager – Clinical Science (Medical Science)
- Business Unit: MACR
- Location: Mumbai (Sun House – Corporate Office)
- Employment Type: Full-Time
- Department: Clinical Science / Medical Science
Key Responsibilities:
- Lead medical science activities for clinical trials, including preparation of study synopsis, clinical protocols, and Clinical Study Reports (CSR).
- Present clinical study proposals before the Subject Expert Committee (SEC) during regulatory meetings.
- Plan publication activities for clinical journal manuscripts, abstracts, and scientific articles in this Clinical Trial Job in Mumbai.
- Collaborate with statisticians to identify additional clinical data analyses and support scientific publications.
- Work closely with clinicians and Key Opinion Leaders (KOLs) to optimize clinical trial design, comparators, and study endpoints.
- Review and approve patient eligibility through the Interactive Response Technology (IRT) system at SUN Pharma Careers.
- Coordinate with the data management team to review data management plans, coding plans, SAE reconciliation, CRF completion guidelines, and edit check specifications.
- Ensure timely data cleaning, database lock, and generation of Tables, Figures, and Listings (TFLs).
- Collaborate with biostatisticians on sample size calculations, Statistical Analysis Plans (SAP), and review of blinded or mock TFLs.
- Prepare protocol-specific risk assessment plans addressing clinical safety and operational risks.
- Train study teams on clinical protocols and study endpoint requirements.
- Resolve protocol-related queries from investigators and Ethics Committees.
- Perform medical monitoring activities, including patient eligibility assessments, endpoint reviews, safety evaluations, and medical history assessments.
- Review Adverse Event (AE) and Serious Adverse Event (SAE) reports and provide timely medical recommendations.
Educational Requirements for the Clinical Trial Job:
- MBBS degree from a recognized medical institution.
- MD in Pharmacology is mandatory.
- Candidates with other relevant medical qualifications may also be considered.
- 5–8 years of relevant experience in Clinical Science, Clinical Research, or Medical Monitoring.
- Experience in clinical development and medical monitoring across multiple therapeutic areas is desirable.
Skills Required:
- Strong expertise in Clinical Science and Clinical Pharmacology.
- Experience in medical monitoring and clinical trial oversight.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
- Clinical protocol development and Clinical Study Report (CSR) writing.
- Scientific and medical writing expertise.
- Experience with Statistical Analysis Plans (SAP) and TFL reviews.
- Clinical data interpretation and safety assessment.
- Knowledge of Interactive Response Technology (IRT) systems.
- Excellent leadership and cross-functional collaboration skills.
- Strong analytical, communication, and presentation abilities.
- Ability to work effectively with investigators, KOLs, statisticians, and regulatory teams.
- Project management and decision-making skills.
Benefits of the Clinical Trial Job:
- Join India’s leading pharmaceutical company with a strong global presence.
- Lead high-impact clinical science and drug development projects.
- Collaborate with renowned clinicians, statisticians, and Key Opinion Leaders.
- Gain exposure to regulatory submissions, clinical trial strategy, and global clinical development.
- Contribute to scientific publications and presentations at national and international forums.
- Work in a collaborative and innovation-driven environment.
- Access continuous learning, leadership development, and career advancement opportunities.
- Competitive salary and comprehensive employee benefits.
- Opportunity to influence clinical research programs across multiple therapeutic areas.
- Be part of Sun Pharma’s mission to develop innovative therapies that improve patient outcomes worldwide.
