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Bristol Myers Squibb Associate Director, Clinical Data Standards, Line Manager in Berkeley Heights, New Jersey

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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. Shares the vision for global standards strategy targeted to improve organization productivity, consistency, and quality while maintaining an innovative and flexible mindset to ensure study milestones are met (e.g. FPFV, DB Lock). Understand the complex and interdependent relationships between protocol development, data collection and analysis and reporting. Participates in standards governance by working in a fast paced, matrix environment providing recommendations and decisions on clinical and analysis related issues.

Responsibilities include:

  • Providing leadership of clinical data standards activities across multiple clinical development programs.

  • Management of a team of standards professionals in planning, coordination, and timely delivery of global standards elements for study database consumption.

  • Ensuring adaptive management of a standards team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

  • Managing the book of work for global standards requests. Assigning resources to standards requests and initiatives and regularly monitoring workloads to avoid delays in delivery due to resource constraints. Forecasting future resource needs based on the book of work.

  • Providing ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowering and holding staff to high quality performance and delivery.

  • Ensuring procedural documents are reflective of industry standards, easily followed, and regularly maintained.

  • Contributing to the development and application of smart systems and optimal approaches to support the end to end clinical trial data lifecycle, from collection through submission.

  • Holding accountability to resolve issues and proactively develop solutions, within the functional and across functions.

  • Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading global standards competency.

  • Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

  • Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

  • Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing standards activities on behalf of BMS.

  • Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, Global Biometrics Sciences, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

  • Representing the Company in interactions with key external partners as part of any committee or industry group relating to data standards.

Job Requirements

  • At least 8 years of global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices, including 3 yrs of line management experience. Immuno-Oncology therapeutic experience is highly desirable.

  • Experience in the management of clinical trials including startup, conduct, and reporting activities.

  • Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.

  • Experience interpreting Health Authority regulations with a strong compliance background.

  • Broad experience in various clinical database tools and applications for data collection, review, and the production of tables, listings, and graphs.

  • Knowledge of data integration strategies and practices in support of external partnerships, strategic sourcing, and third party data acquisition.

  • Demonstrated ability to lead high-performing multidisciplinary teams and build alignment across functional areas for both drug programs and continuous improvement projects.

  • Skilled in project planning and management including resourcing, risk assessment, crisis management, and timeline projections.

  • Strong negotiation and collaboration skills with ability to drive resolution of complex issues.

  • Experience with Medidata Rave is a plus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

Company: Bristol Myers Squibb

Req Number: R1545995

Updated: 2021-09-23 02:34:23.138 UTC

Location: Berkeley Heights,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.