Bristol Myers Squibb Clinical Data Transparency Manager in Tampa, Florida
The Clinical Data Transparency Manager will lead the strategic development of activities and resources in support of the following functional areas: Clinical Trial Data Sharing and Lay Language Summaries for Clinical Trials
• Manages and oversees the team responsible Clinical Trial Data Sharing.
• Develop and oversee the lay language process for sharing data to patients of BMS Sponsored studies
• Responsible for providing oversight and project management related to the planning and execution of operational activities for ensuring accuracy, consistency, and completeness of Bristol-Myers Squibb clinical trial data sharing policy and practices in alignment with the FDA Amendment Act, the PhRMA/EFPIA principles for responsible data sharing and evolving . This role requires an understanding of the drug development process and working within internal and global external databases. Works cross-functionally to evolve global data sharing processes, procedures, systems and related training and communication (training pertains to other Clinical Trial Transparency (CTT) team members and outside functions).
• Identifies and leads activities that support evolving strategy for clinical trial data disclosure
• Prioritizes activities and provides strategic input; anticipates and identifies potential issues and creates contingency plans
• Ensure team members complete timely fulfillment of data sharing requests
• Represents the CTT team on internal and external workstreams related to automation systems and other proposed changes that may impact policy related to clinical trial data transparency
• Perform analytics and report on adherences to regulatory requirements and BMS Policy and cycle-times
• Information Technology Operations & Systems Lead for CTT (i.e. Eclipse enhancements, CTD application, etc.)
• Minimum of 5 year work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.)
• Experience entering data into the NIH Database
• Demonstrated Excel and analytical skills, working knowledge of SharePoint
Ideal Candidates Would Also Have:
• Knowledge of Clinical Trial Disclosure NIH and EU regulations
• Working knowledge of clinical trials, Clinical Trial Management Systems
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.