Work as Clinical Trial Disclosure Manager at Bristol Myers Squibb

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.

Post : Manager, Clinical Trial Disclosure

Job Description
The Clinical Trial Disclosure Manager will provide the operational support of :
• Redaction of clinical trial documents in accordance with evolving global regulations.
• Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other 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.
• Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
• 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

Additional Information
Job ID : R1587868
Location : Hyderabad - TS - IN
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th February 2025