Manager, Clinical Data Manager Study Lead
New
R
RegeneronClinical research
Source API remote eligibility restrictions: United StatesFull-TimeManager
Salary114,800 - 187,400 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 7 or more years of clinical data management experience
Requirements
- Hold a bachelor's degree or have equivalent experience in Mathematics, Science, or a related field.
- Have at least 7 or more years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
- Perform quality review and inspection-readiness tasks to meet quarterly Inspection Readiness Review compliance.
- Follow identified gaps through resolution and escalate as necessary.
- Travel 25%.
Responsibilities
- Serve as the data management study lead and primary point of contact for clinical study teams, external data vendors, and CROs.
- Oversee data management activities across assigned studies from study start-up through archiving.
- Provide data management expertise and hands-on support for eCRF and database design, data quality, and status reporting.
- Oversee data quality review and data acceptance before data analyses 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.
- Oversee CRO data management activities, electronic case report forms, clinical trial databases, and electronic edit checks.
- Identify data quality, CRO performance, documentation, and process gaps; follow through on resolution and escalate as needed.
- Review and approve study documentation, including data management plans, case report forms, completion guidelines, validation specifications, and data transfer specifications.
- Oversee study deliverables, timelines, snapshot and lock plans, status metrics, data quality, risks, and issue remediation.
View Full Description & ApplyYou'll be redirected to the employer's site
