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.
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 Regulation and 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 recent staff and develops job aids, work instructions, and user guides, as needed
Uniquely Interesting Work, Life-changing Careers
With a single vision