Bristol-Myers Squibb Company

Clinical Trial Results Reporting Specialist

Location
Tampa, FL, US
Posted
May 12, 2018
Ref
R1504007
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 Clinical Trial Results Reporting Specialist will provide the operational support of Clinical Trial Registration, Clinical Trial Disclosure, and Clinical Trial Data Sharing

• 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 trials data to ensure accuracy and completeness

• Develops lay language summaries geared toward patients using the CSR, statistical data and study protocol as source documents using knowledge of biology or other science field

• 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 workstreams 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

• Bachelor's degree in a life science field • Minimum of 3+ years overall work experience• Demonstrated Excel and analytical skills• Scientific writing experience and basic statistical knowledge, preferred.• Basic understanding of global pharmaceutical drug development or clinical trial process. Familiarity with clinical study reports, protocols, and statistical analysis plans, preferred.• Demonstrated ability to work independently. Ability to manage timelines and quality of work using strong organization, communication, and interpersonal skills in a cross-functional team.