Senior Clinical Data Manager

🕒 Yesterday

🇺🇸 United States – Remote

💵 $115.5k - $187k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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 and maintain clinical data systems and infrastructure • Identify, set up, test, and provide technical oversight of EDC, IRT, ePRO, ECG, and other external data-source technologies • Drive data standards strategy and compliance across the data continuum, including adherence to CDISC/CDASH standards for regulatory submissions • Partner with internal stakeholders, CROs, and technology vendors on requirements, timelines, deliverables, and performance expectations • Oversee vendor technology platforms and processes for regulatory, quality, and inspection readiness • Develop and manage data management documentation, including data management plans and data transfer plans • Manage validated automated data flows for internal and external data • Monitor timelines, milestones, and deliverables; communicate risks, metrics, and status to cross-functional teams and leadership • Generate and review in-process data reports and listings for trial oversight, safety review, and data review activities • Provide data management input into protocols, protocol amendments, clinical study reports, and statistical analysis plans • Ensure data integrity, quality, and regulatory compliance, supporting GCP inspection readiness • Contribute to best practices, SOPs, and scalable data management processes for a growing clinical portfolio • Report to the Senior Director of Data Sciences

🎯 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 • Expert knowledge of electronic clinical data systems, including multiple vendor EDC platforms and related clinical trial technologies • Proven 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 with Pre-IND, IND, NDA, and/or BLA strongly preferred • Demonstrated experience supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials • Phase I–III experience preferred • Experience in CNS, oncology, and/or rare disease indications is a plus • Excellent project planning and organizational skills, including prioritizing competing demands, managing timelines, and delivering high-quality work in a fast-paced environment • Strong analytical skills, intellectual curiosity, and proactive problem-solving approach • Exceptional interpersonal, communication, and presentation skills, with the ability to influence and collaborate across cross-functional teams and with external partners • Strong critical and strategic thinking abilities for analyzing complex data and operational challenges • Role is based in the US with occasional travel

🏖️ Benefits

• Company bonus depending in part 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 • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups open to all employees