Manager, Clinical Data Management Study Lead

🔥 10 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.

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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

• Provide oversight of lead Data Managers on assigned clinical data management studies • Serve as DM study lead and primary point of contact for clinical study teams, external data vendors, and CROs • Oversee data management activities from study start-up through archiving • Provide data management expertise and hands-on support related to eCRF and database design, data quality, and reporting • Oversee data quality review and data acceptance procedures before data analyses and/or database lock • Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding • Support study database transfer, locking, and archiving • Manage scheduling and time constraints across multiple projects • Prepare recommendations for improved data management processes and data flow • Oversee CRO data management activities and ensure eCRF, clinical trial database, and electronic edit check execution follows SOPs and WIs • Identify data quality, CRO performance, documentation, and process execution gaps and ensure resolution • Document sponsor oversight from protocol review through study close-out • Review and approve study documentation • Perform quality review and inspection readiness tasks for quarterly IRR compliance • Lead and oversee data management deliverables, timelines, snapshot/lock plans, status metrics, and program-level inputs • Monitor data quality and data issue remediation • Identify risks, propose mitigations, and proactively escalate operational, vendor, or CRO issues • Provide limited program-level support for small programs

🎯 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 biotechnology, pharmaceutical or health related industry • Expertise in clinical data management • Experience with eCRF and database design, data quality, and database/data quality status reporting • Experience with data quality review and data acceptance prior to data analyses and/or database lock • Experience managing data transfers with CROs and third-party data sources • Experience with SAE/AE reconciliation and MedDRA/WHO-DD coding • Experience with clinical trial databases and electronic edit checks • Quality review and inspection readiness experience • Ability to develop deliverable timelines, snapshot/lock plans, metrics, and status updates • Ability to monitor data quality, remediate data issues, identify risks, propose mitigations, and escalate operational or vendor/CRO issues • Ability to travel up to 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