New · posted Nov 11
Eli Lilly · Pharmaceuticals
Associate Director - Clinical Study Build - eCOA
- Indianapolis, IN
- On-site
- Full-time
- Director
The role
The Associate Director /Director, Clinical Study Build - eCOA is a leadership role within Data and Analytics-Strategic capabilities organization and is accountable for delivering data collection systems for Lilly’s portfolio of trials. The scope of the Associate Director/Director, Clinical Study Build role includes development and delivery of trial level database builds for clinical data collection. The Associate Director/Director is also responsible for coaching and developing staff to enhance scientific, technical, and operational depth. This role requires an in-depth understanding of global clinical data collection modalities, technologies, study database build and practices.
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
What you need
Minimum Qualification Requirements
- Master’s degree with 3-5 years of experience (or bachelor's degree with 7 or more years of experience) in clinical drug development or a related field, with strong technical expertise in database build / data collection technology
- Previous people management experience
- Demonstrated ability to effectively partner/influence and drive a technical project to deliver positive results.
- In depth understanding of clinical data flow
What you'll do
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Delivery
- Accountable for delivery of trial level internal study builds for eCOA /ePRO/CRO and direct data collection
- Understand data collection strategies associated with disease indications and implementation of design best practices across builds
- Partner closely with other leaders within DNA and drive build and delivery of indication level libraries
- Collaborate with other functional leaders to provide proactive strategic, scientific, and technical input on clinical data collection modalities
- Own business requirements relevant to portfolio needs and help shape road map for Lilly’s internal eCOA platform (Atom5)
- Ensure strong linkages exist between study design, build, study execution, analytics, and study decommissioning
Enterprise Leadership
- Sustain eCOA build acceleration and user experience improvement initiatives.
- Foster a culture of innovation with DNA strategic capabilities organization enabling incremental improvements as well as transformational changes
- Stay current with external environment and technology evolution in data collection space
- Lead large-scale cross-Business Unit/Therapeutic Area projects or programs with high complexity
- Represent the Data and Analytics organization at appropriate internal and external forums
- Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China
Technical and People Leadership
- Develop in-depth understanding of data collection platforms used by Lilly
- Participate in the recruitment, development, and retention of a scientific, technical, and operationally capable R-Path talents. .
- Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical database build and delivery
- Create a team culture that fosters inclusion and innovation and values diversity
- Responsible for effective resource planning
- Responsible for supervising eCOA study build staff, as assigned, including aspects of training, mentoring, goal setting, performance management, and engagement.
- Help remove any barriers that impede team from achieving company, functional, and individual objectives.
Pay and benefits
$124,500 – $182,600 a year
Employer providedOther Information/Additional Preferences
- Advanced degree (e.g., MS, PhD) in a scientific or health care field
- Proven ability to develop diverse organizational talent with next-level potential
- Passionate about technology adoption
- Domestic and international travel may be required
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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$124,500 - $182,600
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.
Company bonus
401(k)
Pension
Vacation benefits
Medical, dental, vision and prescription drug benefits
Flexible spending accounts
Where you'll work
Indianapolis, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Indianapolis, IN
From the posting
About Lilly
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 29% below the US median for Clinical Data Management roles at this level.
This roleEmployer provided
Director roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $124,500 | — | $182,600 |
| All US (middle half) | $187,750 | $215,000 | $241,625 |
This role: Eli Lilly's own published range. Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 65 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Lilly's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Clinical trial conduct2
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA require
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- NMPAChina NMPA(official source, opens in a new tab)China's National Medical Products Administration
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
Company hiring pulse
Lilly on Regulatory Jobs
- 53
- Open roles
- 53
- Distinct roles
- 10
- Locations
By discipline
- Quality29 55%
- Clinical17 32%
- Regulatory7 13%
By level
- Director24 45%
- Senior & Principal16 30%
- Associate & Specialist7 13%
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Associate Director - Clinical Study Build - eCOA at Lilly
Open until filled. $125K–$183K a year, employer provided.