Manager, Clinical Trial Disclosure Job in Bristol Myers Squibb

Role Overview: Clinical Trial Disclosure Manager

The Clinical Trial Disclosure Manager will provide operational support for the redaction of clinical trial documents in line with evolving global regulations. This role will play a critical part in ensuring compliance with global disclosure requirements and will collaborate with key stakeholders across the organization.

Key Responsibilities

• Redaction of Clinical Documents: Lead the redaction process of clinical trial documents in compliance with global regulations such as EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), and the EU Clinical Trial Regulation.
• Training and Change Management: Develop training programs and drive change management for novel processes related to the EU Clinical Trial Regulation and other evolving regulations.
• Cross-functional Collaboration: Work closely with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other key stakeholders to operationalize redaction requirements.
• Track Redaction Book-of-Work: Manage and track the redaction process and compile performance metrics and volume reports.
• Provide Support to CT Results Managers: Assist the CT Results Managers as required and offer operational support.
• Monitor Regulatory Environment: Stay up to date on global regulatory requirements and disclosure regulations.
• Process Improvement: Collaborate with internal and external stakeholders to improve processes and address any unmet needs.
• Training and Documentation: Train new staff and develop job aids, work instructions, and user guides to support ongoing operations.

What You Bring to the Role

• Strong knowledge of global clinical trial disclosure requirements and experience working with regulations such as EMA Policy 0070 and the EU Clinical Trial Regulation.
• Ability to develop training programs, facilitate change management, and adapt to new regulatory frameworks.
• Excellent collaboration skills to work with cross-functional teams and key internal and external stakeholders.
• Detail-oriented with the ability to manage multiple tasks and track performance metrics.
• Strong communication skills, both written and verbal, to effectively convey information to diverse audiences.
• Experience in process improvement and the ability to manage operational changes efficiently.