FIU Manager – Model & Analytics
SouthState Bank
Senior Manager, Clinical Data Management
Generate Biomedicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $196,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as the primary data management representative on cross-functional study teams
- Lead the development, review, and maintenance of data management documentation, including Data Management Plans (DMP), CRF Completion Guidelines, and Data Review Guidelines
- Oversee user acceptance testing (UAT) of eCRFs and associated edit checks
- Conduct data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
- Review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
- Collaborate with CROs to manage timelines and deliverables for data management activities
- Contribute to database lock activities, ensuring audit readiness and data integrity
- Maintain and QC study-specific trackers and metrics dashboards
- Create and manage data deliverable timelines and tasks
- Review and provide feedback on vendor data transfer agreements, transfers and reconciliation
- Provide support to the Clinical Data Management Lead on study-related tasks and initiatives
Requirements
- BS with 8+ years or MS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings
- Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF)
- Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes
- Proficiency in industry data standards including CDISC, SDTM, and CDASH
- Prior experience collaborating with CROs on clinical studies
- Highly organized with excellent communication and interpersonal skills
- Experience in small biotech environments highly preferred
Benefits
- Eligible for an annual bonus
- Equity compensation
- Competitive benefits package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementdata cleaningdiscrepancy managementdata reconciliationuser acceptance testingdata quality metricsdatabase lock activitiesstudy-specific trackersmetrics dashboardsdata deliverable timelines
Soft skills
organizational skillscommunication skillsinterpersonal skills
