Senior Clinical Data Manager

Eli Lilly US, Remote Updated 8 September 2026
PharmaBiotechCROClinical ResearchRegulatory AffairsQuality Assurancegcpsasclinical data managementedcphase iregulatory submission

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 owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work ® in 2026. ​ 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 Qualifications: Bachelor’s or Master’s degree with a minimum of 6 &#43; years of hands ‑ on clinical data management experience in a pharmaceutical or biotechnology environment. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. 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. </div

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