Clinical Trial Disclosure Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Job Title Clinical Trial Disclosure Specialist (D5)

Division Research & Development

Functional Area Description Global Development Operations / Global Clinical Compliance & Continuous Improvement / Global Clinical Documents, Submission and Disclosure / Clinical Trial Transparency Position Summary /

Objective The Clinical Trial Disclosure Specialist will 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.

Position Responsibilities

• 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 Version 1.0 Employee Job Profile – Job Description • 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

Degree Requirements

• BA/BS or MA/MS in scientific or medical field Experience Requirements

• 3 years relevant work experience in a scientific or medical field; 5 years (at least 3 years of relevant disclosure experience) with BA/BS

• US military experience will be considered towards industry experience requirements

Key Competency 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

Travel Required On an as needed basis.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com