Remote CDM Manager: Clinical Data Oversight Lead

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Manager CDM to oversee lead Data Managers on assigned clinical studies. You will provide expert data management support, ensure data quality, and coordinate with external vendors and CROs to meet project timelines and Regeneron standards.

Responsibilities include designing eCRF/database solutions, overseeing data quality and transfers, and maintaining study databases from protocol review through close-out.

Qualifications

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field with 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: Ensure deliverable timelines are developed according to the business need and program objectives.
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
• Ensure regular status updates with metrics are provided to CST.
• Provide program level input to & monitor deliverable timelines.

Responsibilities

• Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more complex studies.
• 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 constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Perform & document the oversight of CRO data management activities for assigned studies: Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs.
• Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close-out.
• Escalate and follow to resolution as necessary.

Skills

Data management leadership

Clinical data management

Stakeholder communication

Regulatory collaboration

Education

Bachelor degree or equivalent in Mathematics, Science or related field

Tools

MedDRA

WHO-DD

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Manager CDM to oversee lead Data Managers on assigned clinical studies. You will provide expert data management support, ensure data quality, and coordinate with external vendors and CROs to meet project timelines and Regeneron standards.

Responsibilities include designing eCRF/database solutions, overseeing data quality and transfers, and maintaining study databases from protocol review through close-out.