🏷️ Job Title: Manager, Clinical Trial Disclosure
📍 Location: Hyderabad, Telangana, India
🕒 Employment Type: Full Time
🏢 Company: Bristol Myers Squibb (BMS)
🧭 Position Overview
As a Manager, Clinical Trial Disclosure, you will oversee and operationalize clinical trial disclosure processes in compliance with global regulations, including the EU Clinical Trial Regulation, EMA Policy 0070, and Health Canada Public Release of Clinical Information (PRCI). The role involves driving process improvements, training, and ensuring timely redaction and disclosure of clinical documents.
⚙️ Key Responsibilities
Clinical Trial Disclosure & Operations
Develop training and drive change management for new processes related to global clinical trial regulations.
Manage and coordinate redaction of clinical documents per EMA, Health Canada, EU CTR, and other regulations.
Collaborate with Global Development Operations, Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
Provide vendor and CRO oversight for document redaction and data sharing.
Work with IT to implement technology solutions for clinical trial disclosure.
Manage and track redaction book-of-work; compile and report volume and performance metrics.
Provide operational support to Clinical Trial Results Managers as required.
Monitor global regulatory environment and maintain up-to-date knowledge of disclosure requirements.
Communicate with internal and external stakeholders to improve processes and address unmet needs.
Training & Documentation
Train new staff and develop job aids, work instructions, and user guides as necessary.
🎓 Qualifications & Experience
Education:
MA/MS in scientific or medical field required
BA/BS with 5 years relevant scientific or medical work experience also considered
Experience:
2–3 years of transparency (clinical trial disclosure) experience
5+ years relevant experience in a scientific or medical field
Skills & Abilities:
Deep understanding of US, Canada, and EU clinical trial disclosure regulations and policies
Comfortable working with and discussing scientific data
Strong project and stakeholder management skills
Ability to work independently and proactively seek support when needed
Exceptional written and oral communication skills
Strong organizational skills, able to multitask and prioritize effectively
🌍 Work Environment & Culture
BMS promotes a challenging, meaningful, and life-changing work environment, emphasizing balance, flexibility, and employee growth.
The company encourages applying for roles even if experience does not perfectly match the job description.
Employees are empowered to participate in clinical trials globally and are expected to uphold BMS values: passion, innovation, urgency, accountability, inclusion, and integrity.
🏢 On-site Protocol
Site-essential: 100% onsite
Site-by-design: Hybrid (≥50% onsite)
Field-based/Remote-by-design: Ability to travel for work-related visits and meetings as required
⚖️ Equal Employment Opportunity & Safety
BMS ensures accessibility and accommodations for people with disabilities.
Qualified applicants with arrest or conviction records will be considered per local laws.
Employees are strongly recommended to maintain up-to-date COVID-19 vaccinations.
Data privacy policies apply to all recruitment processes.
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