Job Information
Bristol Myers Squibb Associate Director, eCOA Management in Madison, New Jersey
Working with Us
Challenging. 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: careers.bms.com/working-with-us .
Associate Director, eCOA (Electronic Clinical Outcome Assessment) Management
Division
Research and Development (R&D), Global Development Operations (GDO), Global Data Management (GDM)
Functional Area Description
Global Data Management (GDM) is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.
Position Summary
The Associate Director, eCOA Management is a leadership role essential to the operationalization of the eCOA capability for BMS clinical trials, directly contributing to the BMS R&D pipeline. This role reports to the Head of Clinical Data Acquisition within GDM and is based in New Jersey. It is a full-time, office-based position with flexibility to work from home up to 50% of the time.
Position Responsibilities
Provide leadership for end-to-end eCOA operationalization, working closely with vendors, study teams, and other eCOA roles to ensure successful implementation for studies.
Work with stakeholders to understand the workload for studies using eCOA. Assign resources to studies and initiatives, monitor workloads, and forecast future resource needs.
Streamline processes, document templates, and interactions to facilitate effective eCOA implementation.
Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
Participate in the governance framework to ensure effective collaboration with eCOA vendors, including timely resolution of critical issues.
Ensure quality oversight and management of external partners performing eCOA activities on behalf of BMS.
Provide feedback, coaching, and career development to staff, empowering them to deliver high-quality performance.
Maintain procedural documents to reflect industry standards and regulatory requirements, ensuring they are understood and followed by the team.
Resolve complex issues and proactively develop solutions using clear communication and collaborative strategies.
Lead continuous improvement activities to create an industry-leading eCOA capability.
Represent the function in Health Authority inspections and internal audits, ensuring effective preparations and follow-up actions.
Engage and energize employees through communication of goals and business-critical information, focusing on development and retention.
Promote a workplace culture that values diversity, integrity, and accountability.
Develop strong working relationships with stakeholders throughout GDM/GDO/BMS and with eCOA vendors.
Represent the Company in interactions with key external partners as part of any committee or industry group related to eCOA management.
Degree Requirements
- Bachelor's degree required; advanced degree preferred.
Experience Requirements
At least 7 years of global clinical trial expertise, including specific experience with eCOA capabilities and end-to-end eCOA 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 with expertise in clinical trial start-up/execution and eCOA operationalization.
Strong technical expertise in eCOA processes, designs, instruments, and clinical data acquisition/integration.
Knowledge of industry-leading tools and emerging technologies supporting eCOA.
Strong knowledge of GCP/ICH guidelines.
Proven record of resolving complex issues, making decisions with an enterprise mindset, and driving initiatives to completion.
Experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles.
Demonstrated partnership across various collaborative and industry forums.
Sufficient technical expertise to interface with global development and business partners (medical, development, commercial, regulatory, quality).
Influential leadership and communication capabilities to manage, develop, and inspire a geographically diverse team
Travel Requirements
Potential need for periodic travel.
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 Careers
With a single vision as inspiring as Transforming patients' lives through scienceā¢ , 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583004
Updated: 2024-08-15 02:41:49.057 UTC
Location: Madison-NJ
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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