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Manager, Clinical Trial Disclosure

5+ years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🏷️ 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.