Bristol-Myers Squibb Company

Manager, CT Data Sharing and Patient Summaries

Location
Princeton, NJ
Posted
Nov 27, 2018
Ref
R1511988
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 Manager, Clinical Trial Data Sharing and Patient Summaries will lead the strategic development of activities and resources in support of Clinical Trial Data Sharing and development of processes in support of Patient Lay Summaries (PLSs). Key business partners are Global Biostatisticians, Medical Writers, Medical Monitors, Protocol Managers, Development Leads, Clinical Programmers, Publications and Clinical Trial Engagement Leads.

Key Responsibilities and Major Duties:

  • Oversees the processes surrounding all requests for data sharing from qualified researchers as well as the development of lay language summaries
  • Manage and develop book of work, ensuring appropriate tracking of data sharing requests through internal and IRC review
  • Design and deliver training for team and stakeholders. Maintain and supervise job aids, process guides, curricula
  • Communicate requirements for the BoW to stakeholders. Interact with external and internal stakeholders such as investigators, medical monitors, statisticians, medical writers, publications and clinical programmers on data sharing inquiries and their resolution
  • Stay up to date with evolving regulations in the area of Clinical Trial Data disclosure, the sharing of data and information with external entities and the development of Patient Lay Summaries
  • Collaborates with Clinical Trial Registration and Results Manager to develop efficient end-to-end process for Plain Language Summaries
  • Manages the resolution of typically complex clinical trial disclosure issues with internal groups and government agencies
  • Provide oversight to business partners supporting the development of Patient Lay summaries and the anonymization of data set
  • Prioritizes activities and provides strategic input; anticipates and identifies potential issues and creates contingency plans
  • Identifies and leads activities that support evolving strategy for clinical trial data disclosure

Requirements
  • BS, MS, or PhD in scientific or medical field


Minimum Requirements:
  • Bachelor's degree in a science related field with 5+ years of technical (scientific) writing experience or a Master's degree with 2+ years of (scientific) writing experience
  • Demonstrated understanding of US and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc) 
  • Strong working knowledge of CTMS and clinical document management systems 
  • Familiarity and comfortability working with and discussing scientific data 
  • Strong leadership skills.  Able to set ambitious goals for self and team. 
  • Demonstrated ability to work independently and seek out support when needed 
  • Exceptional written and oral communication skills. 
  • Experienced in facilitating tailored presentations to internal and external stakeholder groups.   
  • 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