Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the planning and implementation of clinical data management activities for global development initiatives.

• Design and oversee data management strategies and plans, which encompass data capture tool design, data processing, coding, validation, and continuous data quality supervision.

• Create and maintain clinical data systems and infrastructure, including EDC, IRT, ePRO, ECG, and other external data sources.

• Drive the strategy for data standards and ensure compliance with CDISC/CDASH standards.

• Collaborate with internal stakeholders, external CROs, and technology vendors regarding requirements, timelines, deliverables, and performance expectations.

• Supervise vendor technology platforms and processes to ensure regulatory compliance, quality, and inspection preparedness.

• Draft and manage documentation related to data management, including data management plans, data transfer plans, and validated automated data flows.

• Track timelines, milestones, and deliverables; communicate risks, metrics, and status updates to cross-functional teams and leadership.

• Generate and review in-process data reports and listings for trial supervision, safety, and data review tasks.

• Contribute data management insights into protocols, protocol amendments, clinical study reports, and statistical analysis plans.

• Safeguard data integrity, quality, and regulatory compliance, supporting GCP inspection readiness.

• Contribute to the development of best practices, SOPs, and scalable data management processes.

⛳️ Requirements

• Bachelor’s or Master’s degree with a minimum of 6+ years of practical clinical data management experience in a pharmaceutical or biotechnology setting.

• Authorized to work full-time in the United States; Lilly will not provide work authorization or visa sponsorship.

• In-depth knowledge of electronic clinical data systems, including various vendor EDC platforms and associated clinical trial technologies.

• Proven experience in managing and collaborating with CROs and technical vendors, including oversight of deliverables, timelines, and quality.

• Strong understanding of regulatory requirements affecting clinical data management.

• Experience with regulatory submissions; Pre-IND, IND, NDA, and/or BLA experience is highly desirable.

• Background in supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials.

• Preferred experience in Phase I–III studies.

• Familiarity with CNS, oncology, and/or rare disease indications is an advantage.

• Outstanding project planning and organizational abilities.

• Capability to prioritize competing demands, manage timelines, and produce high-quality work in a fast-paced environment.

• Highly self-motivated and detail-oriented, with strong analytical skills, intellectual curiosity, and a proactive problem-solving approach.

• Excellent interpersonal, communication, and presentation skills.

• Strong critical and strategic thinking capabilities.

• Ability to work collaboratively across cross-functional teams and with external partners.

🏝️ Benefits

• Company bonus based on individual and company performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including employee assistance programs, fitness benefits, and employee clubs and activities.

• Occasional travel required.