Bristol Myers Squibb Company

Senior Manager, EDC Management (Global Library Programmer)

Location
Celgene, NJ, United States
Posted
Sep 01, 2020
Ref
R1529012
Required Education
Bachelors Degree
Position Type
Full time
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.

Job Title

Senior Manager, EDC (Electronic Data Capture) Management

Division

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.

Position Summary

The Senior Manager, EDC Management contributes directly to the success of the BMS R&D pipeline is responsible for the effective development, management, and implementation of the EDC system at a global level.

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

Position Responsibilities
  • Ensuring the EDC system is being developed and managed at a global level for effective use for study databases. Depending on the area of focus, this can include one or more of the following:
  • Developing and implementing the global library strategy and structures.
  • Building, maintaining and documenting the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) in order to facilitate the creation of study level databases to collect clinical trial data.
  • Working with Clinical Data Standards, Data Managers, and EDC Database Developers to implement new or modified global library objects and to develop appropriate timelines for delivery of the global library objects.
  • Ensuring the EDC internal module connections (e.g., Safety Gateway, TSDV) and external system integrations (e.g., with the Clinical Trial Management System and Payment systems) are configured and implemented effectively.
  • Working closely 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.
  • Managing work assignments to ensure timely delivery.
  • Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.
  • Following procedural documents and participating in reviewing and updating of documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
  • Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
  • Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
  • Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.
  • Liaising with and reviewing work delivered by 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 GDMCM, GDO, 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 global library develompent.


Degree Requirements

Bachelors degree required

Experience Requirements
  • At least 5 years of global clinical trial expertise with a focus on EDC global library development, management, and implementation.
  • At least 5 years of clinical database development experience in Rave with experience in global library management and development of standard data collection objects.


Key Competency Requirements
  • Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC development, management, and implementation at a global level (not just at the 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.
  • Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
  • Understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
  • Demonstrated partnership across various collaborative forums.
  • Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
  • Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.


Travel Required (nature and frequency).

Potential need for periodic travel

Describe exposure to any hazards/disagreeable conditions in the work environment.

N/A

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.