Bristol Myers Squibb Life Science Jobs – Apply Now!

Are you ready to make a meaningful impact in clinical research? Bristol Myers Squibb (BMS) is hiring a Study Startup Specialist/Clinical Trial Associate in Mumbai, Maharashtra. This is your opportunity to work on life-changing clinical trials, ensuring compliance with GCP, ICH guidelines, and regulatory requirements. If you have experience in study startup, site activation, and document management, apply now to be part of a global team dedicated to transforming lives.

About Bristol Myers Squibb

Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to transforming patients’ lives through science. With a focus on innovative medicines in oncology, hematology, immunology, and cardiovascular diseases, BMS is at the forefront of groundbreaking research and development. At BMS, we believe in pushing the boundaries of medicine, pioneering cutting-edge treatments, and fostering a culture of collaboration, diversity, and inclusion. Our mission is to discover, develop, and deliver life-saving therapies that address unmet medical needs worldwide. With operations in more than 50 countries, BMS offers a dynamic and rewarding career environment where professionals can grow, innovate, and make a real impact. Whether you are working in R&D, clinical trials, regulatory affairs, or commercial roles, your contributions will help improve the quality of life for millions of patients around the globe.

Study Startup Specialist Job Details: 

Job Role: Study Startup Specialist/Clinical Trial Associate

Locations: Mumbai, Maharashtra, India

Time Type: Full-time

Job Requisition ID: R1590562

Key Responsibilities:

• Responsible for activities related to study start-up and ongoing study document management
• Act as point of contact for local study teams and external stakeholder
• Independently manages study and site-level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
• Support local regulations in preparing and performing submissions for Health Authorities, including follow-up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• In the Study Startup Specialist Job, one needs to prepare and perform submissions for Ethics Committees, including follow-up until approval (protocol, amendments/IB, and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the BMS internal study teams, external site staff, and country ethics committees/IRB to ensure tasks and priorities are aligned with the defined study timelines
• Prepare country Informed Consent Form (ICF) and manage country ICF template
• Review and approval of Site ICFs
• Review and approval of Clinical Trial Package (CTP) documentation
• Update national registries as applicable
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
• When applicable, conduct drug/IMP label review & translation
• Serves as an expert on country regulatory requirements and keeps up to date with evolving regulations in collaboration with Regulatory and legal
• May support the collection and distribution of documents from/to sites, including obtaining insurance certificates
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local-related issues

Minimum Qualifications and Experience for Study Startup Specialist Job:

• Bachelor’s degree required, preferably within life sciences or equivalent
• Thorough understanding of GCP, ICH Guidelines, and Country regulatory environment
• In-depth knowledge and understanding of clinical research processes, regulations, and methodology
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis.
• Good verbal and written communication skills (both in English and local language)
• Minimum of 2 years of industry-related experience.

APPLY ONLINE HERE

Keywords: Bristol Myers Squibb, Study Startup Specialist, Clinical Trial Associate, Mumbai, Maharashtra, India, GCP, ICH Guidelines