Director, eCOA Management

Position Summary

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, is based in New Jersey and is full‑time, office‑based with flexibility to work from home up to 50% of the time.

• Provide comprehensive leadership of the eCOA Management function, ensuring technology, processes, roles and vendor partnerships are optimized and meet industry standards and regulatory requirements.
• Ensure quality development and timely delivery of eCOA instruments and devices designed according to documented specifications, industry and BMS standards.
• Deliver eCOA for studies across Therapeutic Areas, including complex Neuroscience rater studies.
• Ensure eCOA data meets quality standards, is consumable by downstream functions and reliable for analysis.
• Define, document and execute processes related to acquisition and review of eCOA data, including start‑up, system development, scale management, localization/translations, device shipments, data review/data changes, rater training/qualifications, blinded data analytics and other Neuroscience rater study processes.
• Streamline document templates and communications to promote consistency across vendors.
• Define key quality and performance metrics and review results to proactively identify and implement improvements.
• Lead initiatives to establish industry‑leading eCOA capabilities and processes, driving projects from start to finish.
• Hold accountability to resolve complex issues, proactively develop solutions within the function and across functions.
• Use clear communication and collaborative strategies to drive resolution and remove barriers.
• Manage the eCOA book of work and ensure delivery of initial development and post‑production changes for studies.
• Work with line managers to forecast future resource needs and resolve any resource constraints.
• Lead a global team of eCOA Management professionals that contribute significantly to the BMS portfolio of clinical trials.
• Provide ongoing feedback, coaching and career development, including engagement and retention support to staff.
• Empower staff to high‑quality performance and delivery.
• Engage and energize employees through recognition, development and communication of goals/strategies.
• Collaborate effectively with eCOA vendors to ensure quality and timely delivery and to resolve critical issues.
• Communicate and incorporate business functionality requirements into vendor release plans and roadmaps.
• Represent the function for Health Authority inspections and internal audits and ensure follow‑up actions are completed.
• Promote a workplace culture that values diversity of thought, integrity and accountability.
• Develop strong working relationships with key stakeholders across BMS and influence peers and senior management.
• Represent the company with key external organizations in committee or industry group activities related to eCOA.

• Bachelor’s degree required; advanced degree preferred.
• At least 10 years of relevant eCOA, end‑to‑end processes and technology experience, with 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 knowledge of eCOA data acquisition, review and delivery processes required to support submissions 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 enterprise‑level decisions and delivering significant initiatives to completion.
• Demonstrated ability to deliver tangible impact by planning and executing strategic projects…