Associate Director - eCOA Delivery

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

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