Senior Clinical Data Manager

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $105k - $169.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Logo of Eli Lilly and Company

Eli Lilly and Company

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead planning and execution of clinical data management activities for global development programs • Develop and oversee data management strategies and plans, including data capture tool design, data processing, coding, validation, and ongoing data quality oversight • Establish, maintain, test, and provide technical oversight for electronic clinical trial technologies including EDC, IRT, ePRO, ECG, and external data sources • Drive data standards strategy and compliance, including adherence to CDISC/CDASH standards • Partner with internal stakeholders, external CROs, and technology vendors on requirements, timelines, deliverables, and performance • Oversee vendor technology platforms and processes for regulatory, quality, and inspection readiness • Develop and manage data management documentation, data transfer plans, and validated automated data flows • Monitor timelines, milestones, deliverables, risks, metrics, and status • Generate and review in-process data reports and listings for trial oversight, safety, and data review • Provide data management input into protocols, protocol amendments, clinical study reports, and statistical analysis plans • Ensure data integrity, quality, regulatory compliance, and GCP inspection readiness • Contribute to best practices, SOPs, and scalable data management processes

🎯 Requirements

• Bachelor’s or Master’s degree with a minimum of 6+ years of hands-on clinical data management experience in a pharmaceutical or biotechnology environment • Authorized to work in the United States on a full-time basis • Expert knowledge of electronic clinical data systems, including multiple vendor EDC platforms and related clinical trial technologies • 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 • Experience supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials • Excellent project planning and organizational skills • Strong analytical skills, intellectual curiosity, and proactive problem-solving approach • Exceptional interpersonal, communication, and presentation skills • Strong critical and strategic thinking abilities • Pre-IND, IND, NDA, and/or BLA experience strongly preferred • Phase I–III experience preferred • Experience in CNS, oncology, and/or rare disease indications is a plus

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

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