Senior Clinical Data Manager

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $115.5k - $169.4k / 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 • Design data capture tools and manage 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 technologies • 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, including data management plans and data transfer plans • Develop validated automated data flows for internal and external data • Monitor timelines, milestones, and deliverables; communicate 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 • 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; Lilly will not provide work authorization or visa sponsorship • 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 • Experience supporting regulatory submissions • Demonstrated experience supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials • Excellent project planning and organizational skills • Ability to prioritize competing demands, manage timelines, and deliver high-quality work in a fast-paced environment • Strong analytical skills, intellectual curiosity, and proactive problem-solving approach • Exceptional interpersonal, communication, and presentation skills • Ability to influence and collaborate effectively across cross-functional teams and with external partners • Strong critical and strategic thinking abilities • Experience with Phase I–III preferred • Experience in CNS, oncology, and/or rare disease indications is a plus • Pre-IND, IND, NDA, and/or BLA experience strongly preferred

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare flexible spending accounts • 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 • Occasional travel