Clinical Trial Disclosure Specialist
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Clinical Trial Disclosure Specialist will report to the Clinical Trial Disclosure Lead and provide the operational support of:
• Clinical Trial Data Sharing,
• Publication of Patient Lay Summaries and,
• Redaction of clinical trial documents in accordance with evolving global regulations.
Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.
- Manage and coordinate external requests from researchers for BMS clinical trial data with professionalism and adherence to policy and regulation
- Collaborate with Informed Consent Form (ICF) Lead, Development Leads, Legal, Global Biostatistics, and Publications to ensure awareness of data sharing requests and proper safeguarding of the data
- Collaborate with Global Development Operations, Clinical Trial Engagement, and other internal and external stakeholders to establish an end-to-end process for delivering plain language summaries of clinical trial results to patients and the public
- Develop training and drive change management for novel processes related to Plain Language Summaries and the broader EU Clinical Trial Regulation
- 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, redactions and lay summaries preparation, as appropriate
- 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 Specialists, as required
- Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
- Communicates with internal and external stakeholders to improve on processes and manage unmet need
- Trains new staff and develops job aids, work instructions, and user guides, as needed
- BA/BS or MA/MS in scientific or medical field
- 2-3 years of data sharing experience and 5 years relevant work experience in a scientific or medical field with BA/BS
- US military experience will be considered towards industry experience requirements
- Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)
- Preferred experience in Patient Lay Summaries writing
- Familiarity and comfortability 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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