Bristol-Myers Squibb Company

Clinical Data Transparency Associate Manager

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

The Clinical Data Transparency Associate 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:

• BA degree with a 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