Associate Director, EDC Management (Global Library Lead)
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.
Associate Director, EDC (Electronic Data Capture) Management
Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM&CM)
Functional Area Description
GDM&CM is responsible for clinical trial data acquisition, data standards governance, data management, medical coding, data reporting and analytics, and centralized monitoring for trials across the BMS R&D portfolio.
The Associate Director, EDC Management is a leadership role with oversight of EDC global library development, management, and implementation activities and directly contributes to the BMS R&D pipeline.
This role reports to the Director, EDC Management within GDM&CM and is a full-time, office-based position.
- Providing proactive leadership of EDC management activities. Depending on the area of focus, this can include one or more of the following:
- Leading the development/implementation of the global library strategy and structures.
- Leading a team of Global Library Programmers who create/update the standard data collection objects in the global library.
- 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.
- For people managers:
- Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes.
- Managing the book of work, assigning resources to work 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.
- 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.
- 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 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.
- 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.
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.
Key Competency Requirements
- 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.
- 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.
Travel Required (nature and frequency).
Potential need for periodic travel
Describe exposure to any hazards/disagreeable conditions in the work environment.
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.