Clinical Trial Result Specialist

Profile

Job Information

Bristol Myers Squibb

Clinical Trial Result Specialist

in

Princeton

New Jersey

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

Description

The Clinical Trial Results Reporting Specialist is responsible for creation of the clinical trial summary results report form for ClinicalTrials.gov and EudraCT, the management of the review and approval process for these forms, and timely upload into the databases.

The Results Reporting Specialist will partner with Statisticians, Medical Monitors, Medical Writers, Operations Leads and IT.

Key Responsibilities and Major Duties

Identifies result summary data to be disclosed based on the protocol and study report.

Creates the results reporting form for a clinical trial based on information found in the clinical study report.

Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT.

Partners with GBS and external partners to ensure AE files for results disclosure are created and uploaded to the database.

Files reporting extensions (certificates of delay) when appropriate.

Liaises with 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) 

Provides operational support for clinical trial registration maintenance

Assesses revised protocols for impact on registration, and works with the study team on registration updates.

Publishes CSR synopsis on BMS.com

Contributes to improvements of clinical trial data disclosure processes and related documentation.

Requirements

BS, MS, or PhD in scientific or medical field

Minimum of 3 years overall work experience; minimum of 2 years of relevant experience in a scientific, medical, or clinical research field

Demonstrated Excel and analytical skills

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

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com