Director, eCOA Management

Bristol Myers Squibb • Princeton, NJ

20h • Hybrid

About The Position

The Director, eCOA Management is a leadership role accountable for the operationalization of eCOA for BMS clinical trials and directly contributes 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. The position involves providing comprehensive leadership for the eCOA Management function, ensuring technology, end-to-end processes, roles, and vendor partnerships are optimized and in line with industry standards and regulatory requirements. It ensures quality development and timely delivery of eCOA instruments and devices designed according to documented specifications, industry, and BMS standards, particularly for studies across Therapeutic Areas, including complex Neuroscience rater studies. The Director is responsible for ensuring data acquired through eCOA meets quality standards, is readily consumable by downstream functions, and is reliable for analysis. This includes defining and executing processes for eCOA data acquisition and review, such as eCOA start-up, system development, scale management, localization/translations, device shipments, data review/changes, rater training/qualifications, and blinded data analytics. The role also encompasses streamlining document templates, defining key quality and performance metrics, leading initiatives to establish industry-leading eCOA capabilities, resolving complex issues, managing the eCOA book of work, and forecasting resource needs. A key aspect is leading a global team of eCOA Management professionals, providing ongoing feedback, coaching, and career development, and collaborating effectively with eCOA vendors to ensure quality and timely delivery, including incorporating business functionality into vendor release plans/roadmaps. The Director will also represent the function for Health Authority inspections and internal audits, develop and promote a workplace culture that values diversity and accountability, build strong relationships with key stakeholders throughout BMS, and represent the company with external organizations related to eCOA.

Requirements

• Bachelor’s degree required
• At least 10 years of relevant eCOA, end to end processes, and technology experience with specific expertise in implementing eCOA for complex Neuroscience rater studies.
• Successful track record of leading functions, managing staff, influencing stakeholders and vendors, driving strategy and making decisions.
• Deep understanding of clinical trial processes with proven expertise in end-to-end eCOA operationalization in a global arena.
• Expert understanding of end-to-end processes for eCOA data acquisition, review and delivery and what is required of eCOA data to support submissions for studies across Therapeutic Areas including complex Neuroscience rater studies.
• Expert knowledge of industry trends and emerging technologies supporting eCOA.
• Proven record of working effectively with multiple eCOA vendors.
• Expert knowledge of GCP/ICH guidelines.
• Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
• Demonstrated ability to deliver tangible impact by planning and executing strategic projects involving cross-functional stakeholders.
• Strong, clear oral and communication skills, including the ability to craft communications and business cases for senior leadership.
• Demonstrated people management experience.
• Proven experience with applying Systems Development Life Cycle (SDLC) and system validation principles to ensure data integrity and quality.

Nice To Haves

• Advanced degree preferred

Responsibilities

• Providing comprehensive leadership of the eCOA Management function ensuring the technology, end to end processes, roles and vendor partnerships are optimized and in line with industry standards and regulatory requirements.
• Ensuring quality development and timely delivery of eCOA instruments and devices that are designed in accordance with documented specifications, as well as industry and BMS standards.
• Delivering eCOA for studies across Therapeutic Areas, including complex Neuroscience rater studies.
• Ensuring data acquired through eCOA meets quality standards, is readily consumable by downstream functions and is reliable for analysis.
• Ensuring processes related to acquisition and review of eCOA data are well defined, comprehensive, consistent across vendors, and effectively executed across all studies. This includes, but is not limited to, eCOA start up, system development, scale management, localization/translations, device shipments, data review/data changes, rater training/qualifications and blinded data analytics and other Neuroscience rater study processes.
• Streamlining document templates and communications and promoting consistency across vendors.
• Defining key quality and performance metrics and reviewing results to proactively identify/implement improvements.
• Leading initiatives to establish industry-leading eCOA capabilities and processes, driving projects from start to finish.
• 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 and remove barriers.
• Managing the eCOA book of work and ensuring delivery of initial development and post-production changes for studies.
• Working with line managers to forecast future resource needs and to resolve any resource constraints.
• Leading a global team of eCOA Management professionals that contribute significantly to the BMS portfolio of clinical trials.
• 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 recognition, development and communication of goals/strategies.
• Collaborating effectively with eCOA vendors to ensure quality and timely delivery, including effective resolution of critical issues.
• Ensuring business functionality that is important for BMS is clearly identified/communicated to eCOA vendors and is effectively incorporated into eCOA vendor release plans/roadmaps.
• 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 workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
• Developing strong and productive working relationships with key stakeholders throughout BMS, demonstrating the ability to think strategically across R&D, and effectively influencing peers and senior management.
• Representing the company with key external organizations as part of any committee or industry group relating to eCOA.

Benefits

• 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.
• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees