Senior Clinical Data Manager

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $115.5k - $187k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 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 and maintain clinical data systems and infrastructure • Identify, set up, test, and provide technical oversight of electronic clinical trial technologies, including EDC, IRT, ePRO, ECG, and other external data sources • Drive data standards strategy and compliance across the data continuum • Ensure adherence to CDISC/CDASH standards to support regulatory submissions • Partner with internal stakeholders and external 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, communicating risks, metrics, and status to cross-functional teams and leadership • Generate and review in-process data reports and listings for trial oversight, decision-making, safety, 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 • Support Centessa’s clinical programs as a hands-on contributor

🎯 Requirements

• Bachelor’s or Master’s degree • 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 • 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 and a proactive approach to problem solving • 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 in CNS, oncology, and/or rare disease indications is a plus • Pre-IND, IND, NDA, and/or BLA experience is strongly preferred • Phase I–III experience is preferred

🏖️ Benefits

• Company bonus depending, in part, 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