Bristol-Myers Squibb Company

Clinical Data Transparency Manager

Location
Tampa, FL, US
Posted
Apr 12, 2018
Ref
R1121535
Discipline
Clinical, Clinical Data
Required Education
Other
Position Type
Full time
Summary:

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

Responsibilities:

• 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 Requirements:
• 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