Manager, Clinical Data Manager – Study Lead

🔥 0 minutes ago

🇺🇸 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.

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

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 data management study lead and primary point of contact for clinical study teams and external partners on complex studies • Oversee clinical data management activities from study start-up through archiving • Provide data management expertise and hands-on support concerning eCRF and database design, data quality, and reporting • Oversee data quality review and data acceptance 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 study database transfer, locking, and archiving • Manage scheduling and time constraints across multiple projects • Recommend new or improved data management and data flow processes • Oversee CRO data management activities and sponsor oversight documentation • Ensure electronic case report forms, clinical trial databases, and electronic edit checks follow SOPs and work instructions • Identify and resolve data quality, CRO performance, documentation, and process execution gaps • Review and approve study documentation, including data management plans, case report forms, validation specifications, and data transfer specifications • Perform quality review and inspection readiness tasks for quarterly IRR compliance • Lead or oversee study data management deliverables, timelines, snapshot/lock plans, status metrics, data quality monitoring, risk mitigation, and issue escalation • Provide limited program-level support for small programs with limited 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 • Experience in the biotechnology, pharmaceutical, or health-related industry • Expertise in clinical data management for clinical studies • Knowledge of eCRF and clinical trial database design • Knowledge of data quality review and reporting • Experience with data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding • Experience overseeing CRO data management activities • Knowledge of electronic case report forms, clinical trial databases, and electronic edit checks • Ability to perform quality review and inspection readiness tasks • Ability to monitor deliverables, data quality, issue remediation, risks, and CRO/vendor performance • Ability to develop and manage deliverable timelines and snapshot/lock plans

🏖️ 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