Manager, Clinical Trial Disclosure

Bristol Myers Squibb; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Bristol Myers Squibb is seeking a Clinical Trial Disclosure Manager in Hyderabad to provide operational support for redaction of clinical trial documents in line with evolving global regulations. You will coordinate cross-functional teams and vendors to ensure compliant disclosure practices.

The role involves training staff, developing job aids, and driving changes in processes to meet EU CTR, EMA, and PRCI standards, with a focus on efficiency and data integrity.

Qualifications

• Experience with clinical trial disclosure processes.
• Familiarity with global regulatory guidelines (EMA, EU CTR, PRCI) a plus.
• Ability to train staff and document procedures.

Responsibilities

• Redact clinical trial documents per evolving global regulations.
• Coordinate redaction of documents across teams and vendors.
• Develop training and change management for new processes.
• Collaborate with Global Development Operations and Medical Writing to operationalize requirements.
• Provide vendor oversight for data sharing and redaction.
• Support IT in implementing disclosure-related tech solutions.
• Track redaction work and report on volume and metrics.
• Assist CT Results Managers and monitor regulatory environment.
• Communicate with stakeholders to improve processes and address unmet needs.

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

The Clinical Trial Disclosure Manager will provide the operational support of:

• Redaction of clinical trial documents in accordance with evolving global regulations.
• Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
• Develop training and drive change management for novel processes related to the EU Clinical Trial Regulationand other regulations
• Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
• Provide vendor oversight to support data sharing and document redaction, as appropriate
• Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
• Manage and track redaction book-of-work; compile and report on volume and performance metrics
• Provide operational support to CT Results Managers, as required
• Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
• Communicate with internal and external stakeholders to improve on processes and manage unmet need

Train new staff and develops job aids, work instructions, and user guides, as needed

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Responsibilities

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603888 : Manager, Clinical Trial Disclosure