Director, eCOA Management

About this role

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. 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 .

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 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 • 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 encourages open dialogue, upholds integrity, and supports coaching and 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.

Degree / Experience Requirements • 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.

Key Competency Requirements • 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 abil

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