Senior Clinical Data Manager - Lead Global Data Delivery

BioSpace; Indianapolis (IN); On-site; USD 116,000 - 169,000; Full time

Job summary

Lilly in Indianapolis, IN is seeking a Senior Clinical Data Manager to lead and perform hands-on data management across global clinical programs. You will collaborate with cross-functional teams, CROs and vendors to deliver high-quality data for regulatory submissions.

The role requires 6+ years in clinical data management, experience with EDC and CDISC standards, and strong communication skills. Occasional travel to support global development programs.

Qualifications

• Bachelor’s or Master’s degree with 6+ years in clinical data management.
• Authorized to work in the United States full-time; no visa sponsorship.
• Expert knowledge of electronic clinical data systems and multiple vendor EDC platforms.
• Experience managing CROs and technical vendors, including oversight of deliverables, timelines, and quality.
• Regulatory submissions support experience (IND/NDA/BLA preferred).
• Experience in Phase I–III trials; CNS/oncology/rare disease experience is a plus.

Responsibilities

• Lead planning and execution of clinical data management activities for global development programs.
• Develop data management strategies including data capture tool design, validation, and quality oversight.
• Oversee data systems setup, testing, and technical oversight of EDC, IRT, ePRO, ECG and external sources.
• Ensure CDISC/CDASH standards for regulatory submissions.
• Coordinate with CROs and vendors on requirements, timelines and performance.
• Oversee data management documentation and data transfers; monitor timelines and risks.
• Generate in‑process data reports to support trial oversight.
• Contribute to protocols and statistical analysis plans.

Skills

Project planning

Regulatory knowledge

Vendor management

Cross-functional collaboration

Data management

Education

Bachelor’s or Master’s degree

Tools

EDC platforms

Clinical trial technologies

Job description

Lilly in Indianapolis, IN is seeking a Senior Clinical Data Manager to lead and perform hands-on data management across global clinical programs. You will collaborate with cross-functional teams, CROs and vendors to deliver high-quality data for regulatory submissions.

The role requires 6+ years in clinical data management, experience with EDC and CDISC standards, and strong communication skills. Occasional travel to support global development programs.