Bristol-Myers Squibb Company

Clinical Trial Data Transparency Project Manager

Location
Tampa, FL, US
Posted
May 12, 2018
Ref
R1504332
Required Education
Bachelors Degree
Position Type
Full time
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 Data Transparency Project Manager will provide the operational support of Clinical Trial Registration, Clinical Trial Disclosure, and Clinical Trial Data Sharing.

• Serve as an internal and external resource for clinical trial disclosure• Maintain knowledge of regulatory requirements and industry trends related to clinical trial disclosure• Facilitates internal audits of disclosure practices and policies• Leads, participates in, and provides infrastructure to continuous improvement initiatives, including adoption of new technologies for clinical trial disclosure. Assesses project risk and creates contingency plans. • Support and maintain in-depth knowledge of technical systems used for clinical trial disclosure (CTRR, FastTrack, etc)• Design and maintain SharePoint sites related to clinical trial disclosure. Assist with development of job aids and user guides to support the management of clinical trial disclosure. • Provide ad-hoc reports and facilitate reporting of disclosure activities to internal stakeholders• Provide performance and volume metrics, as needed• Support change management activities across the organization• Tracks and assists in planning budgets and manages contracts for CTT projects. Creates timelines, maps deliverables, and reports on project outcomes. • Leads Information Technology Operations & Systems initiatives for CTT (i.e. Eclipse enhancements, CTD application, etc.)

• BS or above in life science discipline

• Minimum 3+ years overall work experience, 2+ years of technical/scientific writing experience, preferred

• Familiarity with pharmaceutical drug development

• Strong written and verbal communication skills

• Strong stakeholder and project management skills/experience

• Demonstrated Excel and analytical skills, working knowledge of SharePoint. Experience using analytics to generate/filter reports.

• Experience developing job aids, user guides, work instructions, presentations, and process maps