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Redefine the way the brain is measured and treated to optimise patient outcomes across the care continuum
Senior Clinical Data Manager
Location
United States
Posted
28 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Data Manager
CoMind
• 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. • Conduct ongoing data review for quality issues and data trends; 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. • Execute database lock activities, including final data review, clean file declaration, and lock documentation in support of regulatory submissions. • Serve as the organization's subject matter expert on regulatory expectations for clinical trial data, ensuring compliance with GCP (ICH E6(R3)), CDISC standards, 21 CFR Part 11, 21 CFR Part 812, ISO 14155, and applicable FDA guidance; maintain inspection-ready documentation in the eTMF and support internal audits and FDA inspections. • Manage data management vendor and CRO relationships, including review of proposals, budgets, and scopes of work, and ongoing tracking of deliverables, metrics, and timelines. • Contribute to the evaluation, validation, and continuous improvement of data management software tools and systems. • Partner closely with the Data Science & Machine Learning (DSML) team to ensure clinical data assets are structured and maintained to support regulatory submissions, clinical decision-making, and advanced analytics; provide input to protocols and other clinical study documents, and serve as data management liaison across DSML, Quality, Regulatory, and Medical Affairs. • 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.
Job 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.
- Preferred: Certification in clinical data management (like CCDM).
- Strong understanding of sponsor-side clinical data management in a medical device, biotech, or pharma environment.
- 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; able to manage multiple changing priorities under tight timelines; detail oriented and collaborative.
- Preferred: sponsor-side medical device or combination product experience; 510(k) or PMA submission data packages; familiarity with SAS or R for data review and supporting analytics or data science teams; SCDM certification (CCDM); exposure to decentralized or hybrid trial models.
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)
- 401k plan with an employer match up to 3%
- Mental health resources
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