Bristol-Myers Squibb Company

Clinical Trial Disclosure Specialist

Location
Princeton, NJ, US
Posted
Nov 27, 2018
Ref
R1511987
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.

The Clinical Trial Disclosure Specialist will provide the operational support of Clinical Trial Data Sharing and Publication of Patient Lay Summaries. Key business partners are Clinical Development/Early Development Leads, Global Clinical Operations, Global Biostatisticians, Publications, Information Technology and Alliance Partners.

Responsibilities:

*Manage external requests for BMS clinical trial data with professionalism and adherence to policy and regulation

* Collaborate with ICF Lead, Development Leads, Legal, Global Biostatistics, and Publications to ensure awareness of data sharing requests and proper safeguarding of the data

* Maintain in-depth knowledge of technical systems used for data sharing and work with IT on potential system enhancements

* Collaborate with Global Clinical Operations, Clinical Trial Engagement, and other stakeholders to establish an end-to-end process for delivering plain language summaries of clinical trial results to patients

* Develop training and drive change management for novel processes related to Plain Language Summaries and the broader EU Clinical Trial Regulation

* Provide operational support to Clinical Trial Results Reporting Specialists, as required

* Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements

* Communicates with internal and external stakeholders to improve on processes and manage unmet need

* Trains new staff and develops job aids, work instructions, and user guides, as needed

Requirements:

* BS or MS in scientific or medical field

* Project management experience

* Strong written and oral communication skills

* Demonstrated Excel and analytical skills, working knowledge of SharePoint

* Minimum of 3 years overall work experience

* Bachelor's degree in a life science field with 2+ years of technical or preferably scientific writing experience