Associate Director - eCOA Delivery

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Position Summary

The Associate Director – eCOA Delivery serves as the primary execution partner for electronic Clinical Outcome Assessment (eCOA) activities at the trial level — owning end-to-end planning, coordination, and delivery of eCOA go-lives and study builds across the portfolio.

This role is the operational backbone of eCOA delivery. The Associate Director (AD) translates strategy and therapeutic area priorities into disciplined trial execution — managing integrated project plans, cross-functional hand-offs, vendor deliverables, and risk mitigation to ensure eCOA activities are completed on time, within scope, and to Lilly quality standards.

This is a senior individual contributor role that operates through influence, operational expertise, and cross-functional collaboration. The AD- eCOA Delivery drives efficiency and standardization at the trial level while feeding critical delivery insights back to eCOA leadership to inform portfolio-level strategy, platform improvements, and systemic issue prevention.

Primary Responsibilities

1. Trial-Level eCOA Delivery & Execution

• Own end-to-end planning and delivery of eCOA trial-level activities, including study build, instrument configuration, translation, migration, and go-live execution on the eCOA platform
• Develop, manage, and maintain integrated project plans for eCOA builds across assigned trials — ensuring milestones, hand-offs, and dependencies are clearly defined and tracked
• Lead and be responsible for all eCOA deliverables across multiple roles and functions, ensuring timeliness, quality, and compliance with GCP, 21 CFR Part 11, and Lilly quality standards
• Conduct regular operational reviews to manage progress, surface issues, and align internal and external stakeholders on trial-level priorities
• Partner closely with the Study Build team to embed improved procedures, tools, and training into future eCOA builds — sharing lessons learned that can be adopted across the portfolio
• Serve as the primary trial-level execution partner to eCOA leadership, providing regular and accurate delivery status, risks, and emerging issues across assigned studies

2. Risk Management & Issue Resolution

• Proactively identify, assess, and communicate trial-level risks — partnering with eCOA leadership and build teams to develop and implement mitigation strategies and contingency plans
• Track and resolve delivery issues within the trial, elevating systemic or multi-trial patterns to leadership for root cause analysis and durable solution
• Monitor vendor deliverables and hold external partners accountable to timelines, quality standards, and contractual commitments — flagging performance concerns to leadership and the Vendor Management group as needed
• Maintain transparency on trial delivery status with all relevant business partners — ensuring no critical issues reach leadership without prior proactive communication from this role

3. Communication & Stakeholder Management

• Coordinate meeting logistics, prepare clear agendas, drive alignment and action items
• Maintain accurate documentation of key decisions, actions, and project changes to ensure organizational transparency and audit readiness
• Facilitate efficient information sharing across global teams and external vendors, adapting communication style to audience needs — operational and outcomes oriented for delivery teams, appropriately summarized for leadership
• Communicate effectively across diverse global teams to support data-driven decision-making and alignment at the trial level
• Contribute delivery-level insights to platform roadmap and process improvement discussions — communicating build challenges, configuration gaps, and platform limitations to inform leadership advocacy with the product team

4. Operational Excellence

• Drive standardization, and efficiency across eCOA trial delivery — lead initiatives to reduce cycle time, eliminate operational waste, and improve build quality
• Identify and communicate evolving process improvement opportunities based on trial delivery experience — partnering with leadership to prioritize and implement systemic improvements
• Measure and enhance team proficiency with new processes, tools, and systems; facilitate shared learning within the delivery team and contribute to broader community of practice sessions
• Engage in shared learning forums and improvement initiatives, implementing agreed process changes and feeding back on their effectiveness at the trial level
• Represent eCOA trial delivery in enterprise-level operational initiatives, contributing to capability advancement across the eCOA ecosystem

What Success Looks Like in This Role

At 90 days:

• Deep familiarity established with assigned trial portfolio, key business partner relationships, and study build processes
• Integrated project plans are in place and actively managed for all assigned studies
• A clear and consistent communication cadence with eCOA leadership and cross-functional partners is operational

At 6 months:

• Recognized by study teams, vendors, and cross-functional partners as a reliable, organized, and proactive delivery partner
• Trial-level risks are being identified and elevated early, with appropriate mitigation plans
• Delivery insights are actively informing portfolio strategy and process improvement initiatives

At 12 months:

• Demonstrable contribution to on-time, high-quality eCOA go-lives across assigned trials
• Lessons learned and process improvements are documented, shared, and incorporated into future builds
• No critical delivery issues are reaching leadership without prior proactive communication from this role

Minimum Qualifications

• Bachelor's degree in STEM field with 5+ years of experience in clinical data management, clinical drug development, or a related field within pharmaceutical, biotech, or CRO industry

Or

• Master's degree in STEM field with 3+ years of experience in clinical data management, clinical drug development, or a related field within pharmaceutical, biotech, or CRO industry

Preferred Qualifications

• Demonstrated experience managing complex clinical trial deliverables or digital health technologies (eCOA, EDC, IRT, DCT, or similar)
• Strong project management and organizational skills, with a proven ability to manage multiple concurrent workstreams in a matrixed environment
• Excellent written and verbal communication skills — able to translate complex operational topics clearly for both delivery teams and senior leadership
• Proven ability to lead through influence, resolve issues, and drive accountability without direct authority
• In-depth understanding of eCOA build processes, including study configuration, translation workflows, migration activities, and eCOA platform capabilities
• Experience working with eCOA vendors and managing vendor deliverables in a sponsor or CRO environment
• Familiarity with Lilly's clinical development processes, CDDA operating model, or eCOA framework
• PMP certification or equivalent project management credential
• Experience in decentralized or hybrid clinical trial models
• Familiarity with GCP, 21 CFR Part 11, or CDISC standards

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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