Job Description:
Bristol Myers Squibb (BMS) is seeking a Clinical Trial Disclosure Manager who will provide operational support in the redaction of clinical trial documents in accordance with evolving global regulations. This role will ensure compliance with various regulatory frameworks, including the EU Clinical Trial Regulation, EMA Policy 0070, and Health Canada’s Public Release of Clinical Information (PRCI). The Clinical Trial Disclosure Manager will work cross-functionally with teams across Global Development Operations, Global Biostatisticians, Medical Writing, and other stakeholders.
Key Responsibilities:
- Redact clinical trial documents according to global regulations and policies.
- Drive training initiatives and manage change for new processes related to EU Clinical Trial Regulation and other evolving global regulations.
- Manage the redaction of clinical documents in accordance with various regulations (EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation, etc.).
- Collaborate with key stakeholders, including Medical Writing, Global Biostatisticians, and Submission Managers, to operationalize redaction requirements.
- Track and report on redaction book-of-work, providing performance metrics.
- Provide operational support to Clinical Trial Results Managers.
- Stay up-to-date on global regulatory changes, ensuring compliance with disclosure requirements.
- Communicate with internal and external stakeholders to improve processes and address unmet needs.
- Assist in training new staff and developing job aids, work instructions, and user guides.
Qualifications and Skills:
- Experience in clinical trial disclosure, regulatory compliance, or a related field.
- Strong understanding of global clinical trial disclosure regulations.
- Ability to work cross-functionally and manage complex processes.
- Excellent communication and training skills.
- Ability to track performance metrics and report on progress.
Bristol Myers Squibb values the balance between work and personal life, offering competitive benefits and a flexible work environment. Join our team to support innovative clinical research and make an impact on global healthcare.
Application Deadline: 15th February 2025
Location: Hyderabad, Telangana, India
Job ID: R1587868
Industry: Pharma/Healthcare/Clinical Research
Application Deadline: 15th February 2025