Associate Director Clinical Data Standards - Line Manager

Profile

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.

Position Summary / Objective

The Clinical Data Standards Team Lead is a leadership role with oversight of the standardization of data collection instruments and directly contributes to the BMS R&D pipeline.

This role reports to the Executive Director, Clinical Data Standards within GDMCM.

Position Responsibilities


Providing leadership of global standards activities across multiple clinical development programs, overseeing a team of standards professionals in planning, coordination, and timely delivery of global standards elements for study database consumption.

Ensuring adaptive management of a global 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.


Degree Requirements

Bachelor’s degree required with an advanced degree preferred

Experience Requirements

At least 7 years of global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Key Competency Requirements


Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition as well as analysis reporting in a global arena.

Strong knowledge of industry clinical data standards and processes (e.g., CDISC: CDASH/SDTM/ADaM, SDSP) and well versed in industry best practice documentation from regulatory authorities (e.g., Technical Conformance Guide, Standards Catalog, CDISC TAUGs, etc.).

Strong knowledge of industry leading eCRF tools (e.g., Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting end to end solutions for data collection through submission (e.g., Metadata Data Repositories, Data Warehouse, Clinical Data Repository).

Strong knowledge of GCP/ICH guidelines.

Technical expertise, technical writing ability, and experience in Systems Development LifeCycle (SDLC) principles.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.


Travel Required

Potential need for periodic travel

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

N/A

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

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