Bristol Myers Squibb BSc Jobs – Life Sciences Apply For Document Coordination Manager Role
Document Coordination Manager, Global Trial Acceleration
Locations: Hyderabad – TS – IN
Time Type: Full time
Posted on: Posted Today
Job Requisition Id: R1581623
Working with Us
Challenging. Meaningful. Life-changing. These aren’t words typically associated with a job, but working at Bristol Myers Squibb is anything but usual. At BMS, uniquely interesting work happens every day across all departments—from optimizing production lines to pioneering breakthroughs in cell therapy. This work transforms lives, not only for patients but also for those driving these advancements. You’ll grow and thrive here through opportunities that are unique in scope, alongside diverse, high-achieving teams. Take your career further than you thought possible.
Bristol Myers Squibb values balance and flexibility in the workplace, offering a variety of competitive benefits, services, and programs that help employees reach their goals at work and in life. Read more at: careers.bms.com/working-with-us.
BMS Hyderabad is an integrated global hub focused on helping patients overcome serious diseases by fostering sustainable and innovative solutions. This science, technology, and innovation center supports a range of technology and drug development activities that will drive the next wave of innovation.
Position Summary
This individual contributor role is responsible for document and CTA package creation, supporting all BMS Clinical Trials across the enterprise, and engaging closely with clinical trial vendors across multiple service categories in R&D.
Key Responsibilities
- Manage and execute centralized activities supporting global trials, focusing on clinical documentation.
- Interact with clinical study sites, Central IRB/IECs, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo), study teams, and other functional areas within BMS.
- Support study teams during start-up, maintenance, and close-out of clinical studies.
- Develop and maintain collaborative working relationships with clinical investigative sites.
- Support outsourcing activities by coordinating with operational teams, support groups, and service providers for study selection, contracting, and execution.
- Global Start-up Documentation Activities:
- Generate, process, track, and distribute Confidential Disclosure Agreements (CDAs).
- Contribute to the creation and distribution of feasibility questionnaires, track responses, and provide feedback to relevant stakeholders.
- Submit potential investigators to CTSS for debarment review and track decisions.
- Review essential regulatory documentation and resolve outstanding issues, including submission of final documents to the electronic Trial Master File (eTMF).
- Oversee site activation, including document review, final sign-off of the site activation checklist, and submission to Regulatory.
- Perform quality control on start-up activities as needed.
- Update and review clinical systems to determine and report the status of clinical trial documents for insourced studies.
- Coordinate certified translation of study-level documentation (e.g., ICF, Protocol, IB).
- Assist with coordinating or creating other study-specific materials, such as pharmacy or investigator site files.
- Act as the central contact for study start-up activities.
- Maintain and track essential documentation, ensuring submission to Regulatory as required.
- Manage correspondence with investigative sites regarding IB updates, protocol amendments, and IRB/IEC approvals.
- Support the Central IRB process, including submissions and approval tracking.
- Ensure accuracy and completeness of eTMF documentation, collaborating with sites, CTM/CTMo, and study teams to resolve issues.
- Lead or ensure the global process for Financial Disclosure Forms is followed.
- May handle creation and management of standardized document templates.
- May oversee CSR appendix generation as needed.
- Other duties as assigned to support clinical trials.
Qualifications & Experience
- BA or BS Degree in Legal, Life Science, Business Administration, or equivalent experience (advanced degree a plus).
- 5 to 7 years of clinical development experience in pharma, biotech, CRO, or similar industries.
- Proficiency in ICH/GCP guidelines, regulatory standards, drug development processes, and Pharma.
- Strong organizational, analytical, and decision-making skills.
- Computer skills: MS Office, Sharepoint, CTMS (Veeva experience preferred).
- Effective stakeholder management with experience in cross-functional, multicultural team collaboration.
- Proven time management skills with flexibility to meet job demands and manage multiple priorities.
- High adaptability and ability to perform in dynamic environments.
Keywords: Document Coordination Manager, Global Trial Acceleration, Bristol Myers Squibb, Clinical Trials, Clinical Documentation, Clinical Development. Bristol Myers Squibb BSc Jobs – Life Sciences Apply For Document Coordination Manager Role. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
