Manager, Clinical Data Manager – Study Lead

🕒 August 14

🇺🇸 United States – Remote

💵 $114.8k - $187.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 18%

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.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Serve as the DM study lead and primary point of contact for clinical study teams and external partners, including data vendors and CROs • Oversee clinical data management activities across all trial stages from study start-up through archiving • Provide expertise and hands-on support related to eCRF and database design, data quality, and database/data quality status reporting • Oversee data quality review and data acceptance procedures before data analyses and/or database lock • Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation, and MedDRA/WHO-DD coding • Support transfer, locking, and archiving of study databases • Manage scheduling and time constraints across multiple projects • Prepare recommendations for new or improved data management and data flow processes • Perform and document oversight of CRO data management activities • Ensure eCRF, clinical trial database, and electronic edit check design, implementation, and maintenance follow SOPs and work instructions • Identify data quality, CRO performance, documentation, and process execution gaps and ensure resolution • Document sponsor oversight activities from protocol review through study close-out • Review and approve study documentation, including Data Management Plans, Case Report Forms, validation specifications, and data transfer specifications • Lead and oversee data management deliverables for assigned studies • Develop deliverable timelines according to business needs and program objectives • Develop snapshot/lock plans and collaborate with the clinical study team for review and approval • Provide regular status updates and metrics to the clinical study team • Monitor data quality and progress of data issue remediation • Identify risks, propose mitigations, and proactively escalate operational, vendor, or CRO issues • Provide limited program-level support for small programs with a limited number of studies

🎯 Requirements

• Bachelor Degree or equivalent experience in Mathematics, Science, or a related field • At least 7 or more years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry • Expertise in clinical data management supporting clinical studies • Experience with eCRF and clinical trial database design • Experience with data quality review, reporting, and database/data quality status • Experience managing data transfers with CROs and third-party data sources • Experience with SAE/AE reconciliation and MedDRA/WHO-DD coding • Experience supporting database transfer, locking, and archiving • Experience with electronic case report forms, clinical trial databases, and electronic edit checks • Ability to identify and resolve data quality, CRO performance, documentation, and process execution gaps • Ability to review and approve Data Management Plans, Case Report Forms and Completion Guidelines, validation specifications, and data transfer specifications • Ability to perform quality review and inspection readiness tasks • Ability to develop and monitor deliverable timelines, snapshot/lock plans, metrics, and data issue remediation • Ability to identify risks, propose mitigations, and escalate issues • Willingness to travel 25%

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required