Senior Clinical Data Manager

Eli Lilly and Company; Indianapolis (IN); On-site; USD 116,000 - 187,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Clinical Data Manager to lead global data management for clinical programs. You will partner with cross-functional teams and external CROs to ensure timely, high-quality data delivery in fast-paced environments.

Ideal candidates have extensive ED C systems experience and regulatory submissions support, with Phase I-III trial exposure; CNS/oncology/rare disease experience is a plus. Occasional travel to support global programs.

Qualifications

• 6+ years hands-on clinical data management experience in pharma/biotech.
• Expert knowledge of electronic clinical data systems and multiple vendor EDC platforms.
• Experience managing CROs and vendors with timelines and quality oversight.
• Regulatory experience supporting submissions; Pre-IND/IND/NDA/BLA preferred.
• Phase I-III trials experience; CNS/oncology/rare disease a plus.
• Strong project planning, communication, and cross-functional collaboration.

Responsibilities

• Lead planning and execution of clinical data management for global programs with high-quality, timely delivery.
• Develop data management strategies including data capture design, processing, coding and validation.
• Oversee data systems infrastructure and external data sources, including EDC, IRT, ePRO, ECG.
• Drive data standards and CDISC/CDASH compliance for regulatory submissions.
• Coordinate with CROs and vendors on requirements, timelines and performance.
• Ensure regulatory, quality, and inspection-readiness across data management domains.
• Produce data management documentation and validated automated data flows.
• Monitor timelines, milestones, and risks; report to leadership.
• Support clinical and regulatory documents with data management input.

Job description

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.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.

Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

The Senior Clinical Data Manager will report to the Senior Director of Data Sciences and serve as a hands-on contributor supporting Centessa’s clinical programs. This role is ideal for an experienced, self-motivated clinical data professional who enjoys working closely with the data, operating with autonomy, and making a direct impact in a fast-paced, growth-oriented environment.

The position partners cross-functionally to support dependable, high-quality clinical data delivery in support of key development milestones. The successful candidate brings strong technical expertise, sound judgment, and the ability to collaborate effectively across distributed teams.

This is an opportunity to apply deep clinical data management experience in an entrepreneurial, collaborative culture where attention to detail, ownership, and proactive problem-solving are highly valued.

Responsibilities:

• Lead the planning and execution of clinical data management activities to support global development programs, ensuring high-quality, timely, and cost-effective delivery

• Develop and oversee data management strategies and plans, including data capture tool design, data processing, coding, validation, and ongoing data quality oversight.

• Establish and maintain clinical data systems and infrastructure, including the identification, set-up, testing, and technical oversight of electronic clinical trial technologies (e.g., EDC, IRT, ePRO, ECG, and other external data sources).

• Drive data standards strategy and compliance, providing guidance across the data continuum and ensuring adherence to CDISC/CDASH standards to support regulatory submissions.

• Partner closely with internal stakeholders and external CRO and technology vendors to align onrequirements, timelines, deliverables, and performance expectations.

• Provide oversight of vendor technology platforms and processes, ensuring they meet regulatory, quality, and inspection-readiness requirements for global development programs.

• Develop and manage data management documentation, including data management plans, data transfer plans, and validated automated data flows for internal and external data.

• Monitor timelines, milestones, and deliverables, proactively communicating risks, metrics, and status to cross‑functional teams and leadership.

• Generate and review in-process data reports and listings to support trial oversight and decision‑making, including safety and data review activities.

• Provide data management input into clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, and statistical analysis plans.

• Ensure data integrity, quality, and regulatory compliance, supporting GCP inspection readiness across all data management domains.

• Contribute to the development of best practices, SOPs, and scalable data management processes to support a growing clinical portfolio.

Minimum Qualifications:

• Bachelor’s or Master’s degree with a minimum of 6+ years of hands‑on clinical data management experience in a pharmaceutical or biotechnology environment.

• Expert knowledge of electronic clinical data systems, including multiple vendor EDC platforms and related clinical trial technologies.

• Proven experience managing and partnering with CROs and technical vendors, including oversight of deliverables, timelines, and quality.

• Strong understanding of regulatory requirements impacting clinical data management, including experience supporting regulatory submissions; Pre-IND, IND, NDA, and/or BLA experience strongly preferred.

• Demonstrated experience supporting multiple complex clinical studies, including early-phase (first-in-human and proof-of-concept) trials; Phase I-III experience preferred. Experience in CNS, oncology, and/or rare disease indications is a plus.

• Excellent project planning and organizational skills, with the ability to prioritize competing demands, manage timelines, and deliver high-quality work in a fast-paced environment.

• Highly self-motivated and detail-oriented, with strong analytical skills, intellectual curiosity, and a proactive approach to problem solving.

• Exceptional interpersonal, communication, and presentation skills, with the ability to influence and collaborate effectively across cross-functional teams and with external partners.

• Strong critical and strategic thinking abilities, enabling effective analysis of complex data and operational challenges.

Work Location:

• The Senior Clinical Data Manager role is a based in the US, with occasional travel.

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 includes: 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

$115,500 - $187,000

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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