Manager, Clinical Data Manager – Study Lead

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $114.8k - $187.4k / year

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2023-10

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 the primary point of contact for clinical study teams and external partners • Oversee all DM activities across all stages of the trial from study start-up through archiving • Provide a high level of expertise in data management to support clinical studies • Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status • Oversee the implementation and execution of procedures for data quality review and data acceptance prior to 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 the transfer, locking, and archiving of study databases • Manage scheduling and time constrains across multiple projects • Prepare recommendations for new or improved processes for data management and data flow • Document DM sponsor oversight activities from protocol review through study close-out

🎯 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 • Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance • Follow through on gaps until resolution, escalating as necessary • Lead/oversee all data management deliverables for assigned studies

🏖️ Benefits

• annual bonuses or other incentive plans • equity awards • pension or retirement benefits • 401(k) company match • health and wellness programs • fitness centers • insurance benefits (e.g. medical, dental, vision, life and disability) • paid time off • family support benefits