Clinical Trial Job at Bristol Myers Squibb | Hybrid Medical Job
Discover an excellent clinical trial job opportunity with Bristol Myers Squibb, a global leader in medical innovation. This hybrid role in Hyderabad is ideal for professionals seeking impactful work through regulatory compliance, documentation excellence, and clinical transparency. If you’re exploring Bristol Myers Squibb jobs or aiming to advance your career with a high-impact medical job, this position offers an outstanding path for long-term growth.
Clinical Trial Job Details:
- Job Position: Manager, Clinical Trial Disclosure
- Work Model: Hybrid
- Location: Hyderabad, Telangana, India
- Company: Bristol Myers Squibb
About the Company
Bristol Myers Squibb is a global biopharmaceutical innovator offering world-class Bristol Myers Squibb jobs that combine challenging, meaningful, and life-changing work. With groundbreaking contributions across scientific research, production optimization, and cell therapy, the company cultivates an environment where employees can thrive. It provides exceptional work-life balance, competitive benefits, and opportunities for personal and professional growth, making it an ideal employer for anyone seeking a long-term medical job in a dynamic setting.
Qualifications
- MA/MS in scientific or medical field.
- 2-3 years of transparency experience
Job Description
This clinical trial job focuses on leading change management, managing clinical document redaction, and ensuring compliance with EU Clinical Trial Regulation, Health Canada PRCI, EMA Policy 0070, and other global frameworks. The role involves collaboration across multiple scientific teams and aligns strongly with key responsibilities often found in high-quality Bristol Myers Squibb jobs and advanced medical job profiles.
Clinical Trial Job – Key Responsibilities
- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other 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.
- 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.
- Provide CRO oversight to support document redaction.
- 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 maintain a working knowledge of disclosure requirements .
- Communicate with internal and external stakeholders to improve on processes and manage unmet need .
- Train new staff and develop job aids, work instructions, and user guides, as needed .
Specific Knowledge, Skills, Abilities
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies.
- Familiarity and comfort level working with and discussing scientific data.
- Project and stakeholder management experience.
- Demonstrated ability to work independently and seek out support when needed.
- Exceptional written and oral communication skills.
- Strong organizational skills with the ability to multitask and prioritize.
