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Job Details


Bristol Myers Squibb

Associate Director, EDC (Electronic Data Capture) Management (R1559923-en-us)

Management

Management

Yearly

No

Princeton, New Jersey, United States

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.

Position Summary:

The Associate Director, EDC Management, EDC Implementation Lead, is a leadership role with oversight, management, and implementation activities and directly contributes to the BMS R&D pipeline. This is an Individual Contributor role.

This role reports to the Director or Associate Director of EDC Management within GDM&CM and is a full-time, office-based hybrid position.

All Associate Directors may be responsible for the following but may focus on specific responsibilities as required by business need:

Responsibilities:
  • Providing proactive leadership of EDC management activities. Depending on the area of focus.

  • Leading the EDC system implementation to ensure adherence to best practices and promotion of effective use by GDM&CM. This includes internal EDC module connections (e.g., Safety Gateway, TSDV) and external system integrations (e.g., with the Clinical Trial Management System and Payment systems).

  • Leading the collaboration with EDC providers and internal stakeholders to ensure the systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the providers’ roadmap.

  • Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.

  • Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained. Ensuring procedural documents are understood by the team and followed.

  • Contributing to the development and application of smart systems/tools and optimal approaches to support the collection of data with a standardized approach.

  • Holding accountability to resolve complex issues and proactively develop solutions, within the function and across functions. Using clear communications and collaborative strategies to drive to resolution.

  • Leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.

  • Authoring procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.

  • Developing and conducting training and/or mentoring team members on key activities and processes.

  • Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause. Ensuring timely closure of CAPA actions.

  • Representing the function for Health Authority inspections and internal audits. Ensuring preparations and follow-up actions are being completed effectively by the team.

  • 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 activities on behalf of BMS.

  • Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

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

Requirements:
  • Bachelors degree required with an advanced degree preferred

  • At least 7 years of global clinical trial expertise with a focus on EDC global library development, management, and implementation. Successful track record of leading through influence, working across complex, global organizational matrices, and effectively managing staff.

  • Deep understanding of the drug development process and clinical trial start-up/execution. Proven expertise in EDC development, management, and implementation at the global level (not just at a study specific level).

  • Strong knowledge of industry leading EDC tools (e.g., Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection.

  • Strong knowledge of GCP/ICH guidelines, industry standard practices and good programming practices

  • Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.

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

  • Demonstrated partnership across various collaborative and industry forums.

  • 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.

#LI-Hybrid

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.