Senior Clinical Data Manager — Global Trials Lead

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

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.