Manager, Clinical Trial Registration and 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.

The Clinical Trial Registration and Results Manager will lead the strategic development of activities and resources in support of the following functional areas: Clinical trial protocol registration and disclosure of results on public registries.

Key Responsibilities and Major Duties:

• Coach, train, and advise team members responsible for registration of clinical trials and reporting of results on public registries
• Provide oversight and project management to business partner and internal resources responsible to maintain the public databases. Liaise with business partner management as appropriate to escalate issues and discuss improvements.
• Ensure accurate, timely, consistent, and complete disclosure of clinical trial data according the Bristol-Myers Squibb clinical trial disclosure policy and in alignment with US, EU, and other evolving regulations
• Maintain continuous knowledge of regulatory requirements, guidance, and industry trends related to clinical trial disclosure
• Communicate book of work and requirements with various stakeholders including Clinical Operations, Global Biostatistics, Publications, Legal, IT and external business partners; provide superior issue resolution as needed
• Work cross-functionally to evolve global disclosure processes, procedures, and systems and drive associated stakeholder training and communication
• Identify and lead continuous improvement initiatives in support of the evolving strategy for clinical trial data disclosure
• Prioritize activities, manage risk, and provide strategic input; anticipate and identify potential issues and create contingency plans
• Work with team to document processes and update user guides and job aids, as needed
• Represent the Clinical Trial Transparency team on internal and external workstreams related to new technology and other proposed changes that may impact policy and procedure
• Performs analytics and reports on adherences to BMS Policy and regulatory requirements for clinical trial disclosure
• This role requires an understanding of the drug development process, experience working within internal and global external databases, and strong stakeholder and project management

Requirements

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

Minimum Requirements:

• BA degree with a minimum of 5 years work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.)
• Experience entering data into the NIH Database
• 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