Bristol-Myers Squibb Company

Clinical Trial Results Specialist

Location
Princeton, NJ, US
Posted
Nov 30, 2018
Ref
R1512185
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 Global Clinical Documents, Submissions and Disclosure organization regroup and unite various existing GCO functions under a single umbrella. Beside the maintenance and governance of the key Model Documents used in BMS sponsored clinical trials, this department is accountable for all the activities involved in the Clinical Trial Application process, those involved in the creation and maintenance of Informed Consent, the preparation of specific documentation in support of global Submissions, the fulfillment of our Disclosure obligations and other Transparency activities.

Description:

The Clinical Trial Results Reporting Specialist will provide the operational support of Clinical Trial Registration, Clinical Trial Disclosure, and Clinical Trial Data Sharing. Key business partners are Global Biostatisticians , Medical Writers, Medical Monitors, Protocol Managers,  Operations Lead, Clinical Programmers, Information Technology and Publications.

Key Responsibilities and Major Duties:
  • Enters Results from clinical trials in US and EU databases
  • Reviews data within a Clinical Study Report (CSR) to determine information required to be publicly reported
  • Analyzes clinical trial data to ensure accuracy and completeness
  • Assists in developing lay language summaries geared toward patients using the CSR, statistical data and study protocol, as needed
  • Files reporting extensions when appropriate
  • Liaisons with the Statisticians, Medical Monitors, Protocol Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results (i.e. publication in a clinical journal)
  • Trains and develops job aids and update user guides as needed
  • Represents Clinical Trial Transparency Group on internal work streams related to proposed changes to automation systems and other proposed changes that may impact this team and their activities
  • Develops and own clinical trial data disclosure processes


Requirements
  • BS, MS, or PhD in scientific or medical field
  • Minimum of 3 years overall work experience
  • Demonstrated Excel and analytical skills
  • Bachelor's degree in a life science field with 2+ years of technical or preferably scientific writing experience

Ideal Candidates Would Also Have:
  • Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred
  • Familiarity with clinical trial protocols and reports desirable


Other qualifications:
  • US military experience will be considered towards industry experience requirements