CoMind
Senior Clinical Data Manager
Remote, US · Senior
Sponsorship not specifiedDetected 35 days ago
GCPMachine LearningData ScienceVendor ManagementFDA RegulatoryMedical DevicesSASLeadershipCommunication
About the role
- The Senior Clinical Data Manager is responsible for leading sponsor-side clinical data management activities across CoMind's clinical development portfolio.
Responsibilities
- Design, build, and configure clinical study databases (EDC, CTMS, eTMF), including eCRF design and annotation, database design specifications, and data validation (edit check) specifications.
- Execute and document user acceptance testing (UAT) of clinical databases, including edit check testing, and manage database amendments and version control across the study lifecycle.
- Develop and maintain SOPs governing data entry screen design, edit check testing, validation approval, and database configuration workflows.
- Serve as the primary point of contact for site users on EDC and eCRF issues, providing troubleshooting, guidance, and escalation support throughout study conduct
- provide equivalent support for eTMF access and issues.
- Manage user account provisioning, role-based access, and timely deprovisioning across the EDC/CDMS and eTMF, maintaining access logs and audit trails in accordance with 21 CFR Part 11 access-control requirements.
- Develop and maintain data management plans, CRF completion guidelines, data review plans, and protocol deviation specifications, ensuring data quality and integrity from source through to submission.
- generate and manage queries, perform discrepancy management, and drive query resolution to clean files.
- Generate and review data listings, summaries, and reports to support ongoing data review by the DSML team and clinical study reports.
- Define data transfer specifications for external data sources (e.g., device, imaging) and perform reconciliation of external data with the clinical database, including SAE reconciliation.
Requirements
- Bachelor's degree with a minimum of 5+ years of clinical data management experience, including demonstrated leadership of end-to-end data management activities.
Nice to have
- Hands-on experience with eCRF design, database build, and edit check configuration
- experience executing UAT scripts for electronic data capture systems.
- Experience administering EDC/CDMS and eTMF user access, supporting site users, and maintaining access controls and audit trails consistent with 21 CFR Part 11.
- Familiarity with clinical data management software
- experience managing data management vendors and CROs.
- Strong working knowledge of GCP, 21 CFR Part 11, 21 CFR Part 812, ICH E6(R3), and ISO 14155.
- Excellent oral and written communication and presentation skills
- detail oriented and collaborative.
Compensation
- Annual Unlimited PTO
Benefits
- Company equity plan
- Annual Unlimited PTO
- Health insurance plan - CoMind contributes 50% to the monthly premium (with the Blue Cross Network)
- Dental insurance (50% Employer Contributions to individual policy)
- Vision insurance (50% Employer Contributions to individual policy)
- Mental health resources
- Strong understanding of sponsor-side clinical data management in a medical device, biotech, or pharma environment.
Company info
- AI is fundamental to our culture - it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively.
Visa & Work Authorization
- The Senior Clinical Data Manager is responsible for leading sponsor-side clinical data management activities across CoMind's clinical development portfolio.
This listing is sourced directly from CoMind's careers page and normalized into a canonical job model.