About the role

Director of eCOA Management overseeing operationalization of eCOA for clinical trials at BMS. Leading a global team to ensure quality and compliance across studies.

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.
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.
Managing the eCOA book of work and ensuring delivery of initial development and post-production changes for studies.
Leading a global team of eCOA Management professionals that contribute significantly to the BMS portfolio of clinical trials.

Bachelor’s degree required with an advanced degree preferred.
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.
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.

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.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays).
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.