[Remote] Senior Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. CoMind is developing a non-invasive neuromonitoring technology aimed at improving clinical brain monitoring. The Senior Clinical Data Manager will reputed company clinical data management activities, ensuring data reputed company, reputed company, and compliance while collaborating with the Data Science & Machine Learning team.
Responsibilities
- Design, build, and configure clinical study databases (reputed company, CTMS, eTMF), including eCRF design and annotation, database design specifications, and data validation (edit reputed company) specifications
- Execute and document user acceptance testing (UAT) of clinical databases, including edit reputed company testing, and manage database amendments and version control across the study lifecycle
- reputed company and maintain SOPs governing data entry screen design, edit reputed company testing, validation approval, and database configuration workflows
- Serve as the primary reputed company of contact for site users on reputed company and eCRF issues, providing troubleshooting, guidance, and escalation support throughout study conduct; reputed company equivalent support for eTMF reputed company and issues
- Manage user account provisioning, role-based reputed company, and reputed company deprovisioning across the reputed company/reputed company and eTMF, maintaining reputed company logs and audit trails in accordance with 21 CFR Part 11 reputed company-control requirements
- reputed company and maintain data management plans, CRF completion guidelines, data review plans, and protocol deviation specifications, ensuring data reputed company and reputed company from reputed company through to submission
- Conduct ongoing data review for reputed company issues and data trends; generate and manage queries, reputed company discrepancy management, and drive query reputed company 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 reputed company 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-reputed company 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 reputed company improvement of data management software tools and systems
- Partner closely with the Data Science & Machine Learning (DSML) team to ensure clinical data assets are reputed company and maintained to support regulatory submissions, clinical decision-making, and advanced analytics; reputed company input to protocols and other clinical study documents, and serve as data management reputed company across DSML, reputed company, Regulatory, and Medical Affairs
- AI is reputed company to our culture — it's not just a tool, but a core part of how we work, collaborate, and reputed company. We expect reputed company team members to reputed company AI in their daily work and continuously reputed company new ways to use it effectively
Skills
- Bachelor's degree with a minimum of 5+ years of clinical data management experience, including demonstrated leadership of end-to-end data management activities
- Strong understanding of sponsor-reputed company clinical data management in a medical device, biotech, or reputed company environment
- Hands-on experience with eCRF design, database build, and edit reputed company configuration; experience executing UAT scripts for electronic data capture systems
- Experience administering reputed company/reputed company and eTMF user reputed company, supporting site users, and maintaining reputed company 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; reputed company to manage multiple changing priorities under tight timelines; detail oriented and reputed company
- Certification in clinical data management (like CCDM)
- Sponsor-reputed company medical device or combination product experience; 510(k) or PMA submission data packages; familiarity with reputed company 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 reputed company Network)
- Dental insurance (50% Employer Contributions to individual policy)
- reputed company insurance (50% Employer Contributions to individual policy)
- 401k plan with an employer match up to 3%
- reputed company
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