[Remote] Senior Clinical Data Manager

Note: The job is a remote job and is open to candidates in USA. CoMind is developing a non-invasive neuromonitoring technology aimed at improving clinical brain monitoring. The Senior Clinical Data Manager will lead clinical data management activities, ensuring data quality, integrity, and compliance while collaborating with the Data Science & Machine Learning team.ResponsibilitiesDesign, build, and configure clinical study databases (EDC, CTMS, eTMF), including eCRF design and annotation, database design specifications, and data validation (edit check) specificationsExecute and document user acceptance testing (UAT) of clinical databases, including edit check testing, and manage database amendments and version control across the study lifecycleDevelop and maintain SOPs governing data entry screen design, edit check testing, validation approval, and database configuration workflowsServe 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 issuesManage 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 requirementsDevelop and maintain data management plans, CRF completion guidelines, data review plans, and protocol deviation specifications, ensuring data quality and integrity from source through to submissionConduct ongoing data review for quality issues and data trends; generate and manage queries, perform discrepancy management, and drive query resolution to clean filesGenerate and review data listings, summaries, and reports to support ongoing data review by the DSML team and clinical study reportsDefine data transfer specifications for external data sources (e.g., device, imaging) and perform reconciliation of external data with the clinical database, including SAE reconciliationExecute database lock activities including final data review, clean file declaration, and lock documentation in support of regulatory submissionsServe 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 inspectionsManage data management vendor and CRO relationships, including review of proposals, budgets, and scopes of work, and ongoing tracking of deliverables, metrics, and timelinesContribute to the evaluation, validation, and continuous improvement of data management software tools and systemsPartner 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 AffairsAI 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 effectivelySkillsBachelor's degree with a minimum of 5+ years of clinical data management experience, including demonstrated leadership of end-to-end data management activitiesStrong understanding of sponsor-side clinical data management in a medical device, biotech, or pharma environmentHands-on experience with eCRF design, database build, and edit check configuration; experience executing UAT scripts for electronic data capture systemsExperience administering EDC/CDMS and eTMF user access, supporting site users, and maintaining access controls and audit trails consistent with 21 CFR Part 11Familiarity with clinical data management software; experience managing data management vendors and CROsStrong working knowledge of GCP, 21 CFR Part 11, 21 CFR Part 812, ICH E6(R3), and ISO 14155Excellent oral and written communication and presentation skills; able to manage multiple changing priorities under tight timelines; detail oriented and collaborativeCertification in clinical data management (like CCDM)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 modelsBenefitsCompany equity planAnnual Unlimited PTOHealth 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 resourcesCompany OverviewCoMind is a noninvasive neural technology company building next-generation neural interfaces. It was founded in 2017, and is headquartered in London, England, GBR, with a workforce of 51-200 employees. Its website is http://www.comind.io.