Senior Clinical Data Manager — Global CDM Lead

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

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.