Senior Clinical Data Manager

Information Technology Senior Management Forum; Indianapolis (IN); On-site; USD 116,000 - 187,000; Full time

Benefits offered by this job

Performance bonus

Comprehensive benefits

Job summary

Lilly is seeking a Senior Clinical Data Manager in the US to lead planning and execution of data management for global development programs. You will design data capture tools, ensure data quality, and maintain data systems across external sources while partnering with CROs and vendors.

The role emphasizes CDISC standards, regulatory readiness, and cross-functional collaboration to support regulatory submissions.

Qualifications

• Bachelor’s or Master’s degree with 6+ years of hands-on clinical data management experience
• Proven knowledge of electronic clinical data systems and trial technologies
• Experience managing CROs and technical vendors, including timelines and quality
• Understanding regulatory requirements impacting clinical data management and submissions
• Experience across multiple complex clinical studies (I–III)
• Strong planning, organizational, and communication skills
• Self-motivated, detail-oriented, with problem-solving mindset
• Excellent interpersonal and cross-functional collaboration abilities

Responsibilities

• Lead planning and execution of clinical data management activities for global programs
• Develop data management strategies including data capture tool design and quality oversight
• Set up and maintain data management infrastructure and external data sources
• Drive data standards and ensure CDISC/CDASH compliance for submissions
• Partner with stakeholders and CROs/ vendors on requirements and deliverables
• Oversee vendor technology platforms for regulatory readiness
• Create and manage data management documents and validated data flows
• Monitor timelines and communicate risks and status to leadership
• Generate in-process data reports for trial oversight and safety reviews
• Contribute data management input to protocols and study reports
• Ensure data integrity and regulatory compliance across data domains
• Help develop SOPs and scalable data processes

Skills

Electronic data systems

CRO/vendor management

Regulatory knowledge

Clinical studies experience

Project planning

Detail-oriented

Communication/presentation

Analytical thinking

Education

Bachelor’s or Master’s degree

Tools

EDC platforms

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 on requirements, 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 Requirements:

• 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 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

$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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