Bristol Myers Squibb - Manager - Clinical Trial Disclosure

- Develop training and drive change management for novel processes related to the EU Clinical Trial Regulationand 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 maintains working knowledge of disclosure requirements

- Communicate with internal and external stakeholders to improve on processes and manage unmet need

- Train new staff and develops 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 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.

Education/Experience/ Licenses/Certifications:

- MA/MS in scientific or medical field.

- 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS.

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