Associate Director, Clinical Data Standards

Company: Disability Solutions
Location: Berkeley Heights
Posted on: November 3, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: .The Associate Director, Clinical Data Standards is a leadership role with oversight to manage Standards Managers, determine resource requirements, prioritize assignments and balance workload. The role includes developing and communicating data standards implementation strategy within department and across functions and directly contributes to the BMS R&D pipeline.This role reports to Director or Executive Director, Head Standards Management & Steward within Clinical & Safety Data Insights and Analytics.Position Responsibilities

• Providing leadership of clinical data 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 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 & Data 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 12 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.
  • 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 Life Cycle (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. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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