Manager, Clinical Data Management – Study Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the lead Data Managers on designated clinical data management studies.

• Ensure the planning and execution of data management deliverables adhere to Regeneron standards and timelines.

• Assist in the creation of SOPs, Working Practices, Data Management Plans, and other data management standards.

• Act as the DM study lead and main contact for clinical study teams and external partners for one or more complex studies.

• Provide data management expertise and hands-on assistance regarding eCRF and database design, data quality, and database/data quality status reporting.

• Supervise data quality reviews and data acceptance processes 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.

• Facilitate the transfer, locking, and archiving of study databases.

• Coordinate scheduling and time constraints across multiple projects.

• Prepare suggestions for enhancing data management and data flow processes.

• Conduct and document oversight of CRO data management activities.

• Ensure electronic case report forms, clinical trial databases, and electronic edit checks are designed, implemented, and maintained in accordance with SOPs and WIs.

• Identify gaps in data quality, CRO performance, documentation, and process execution, ensuring resolution.

• Document sponsor oversight from protocol review through to study close-out.

• Escalate issues and ensure follow-through until resolution.

• Lead and supervise data management deliverables for the assigned studies.

• Monitor data quality, remediation progress, risks, mitigations, and any operational or vendor-related issues.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience in Mathematics, Science, or a related field.

• A minimum of 7 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.

• Conduct quality reviews and inspection readiness tasks to ensure compliance with quarterly Inspection Readiness Reviews (IRR).

• Follow through on identified gaps until they are resolved, escalating as necessary.

• Experience in overseeing data management deliverables for assigned studies.

• Ability to develop deliverable timelines based on business needs and program objectives.

• Capability to create snapshot/lock plans and collaborate with the CST for review and approval.

• Aptitude for providing regular status updates with metrics to the CST.

• Skill in providing program-level input and monitoring deliverable timelines.

• Proficiency in monitoring data quality and assessing the progress of data issue remediation.

• Ability to identify risks, suggest mitigations, and proactively escalate operational, DM vendor, or DM CRO issues.

• Willingness to travel as required, 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 accommodations during the recruitment process where required.