Clinical Data Manager (Temp)

Job Summary

Truvian is seeking a highly motivated and detail-oriented Clinical Data Manager to support the collection, management, quality, and integrity of clinical study data supporting the development and commercialization of medical diagnostic products. The Clinical Data Manager will be responsible for day-to-day clinical data management activities including data monitoring, reconciliation, cleaning, database lock, standardization of clinical and analytical records and preparation of analysis- and regulatory-ready datasets. This is a hands-on role that partners closely with Clinical Operations, Biostatistics, Regulatory Affairs, Quality, R&D, Laboratory Operations, and external CROs and vendors.

What You Will Do

• Manage end-to-end clinical data activities across multiple studies, from study planning and start-up through data ingestion, monitoring, cleaning, reconciliation, integration, database lock, and archival.
• Define data requirements during protocol development and study planning; create, review, and maintain Data Management Plans (DMPs), CRFs, Data Transfer Agreements (DTAs), data review and validation plans, transfer specifications, and related documentation.
• Support EDC system configuration, testing, validation, implementation, and maintenance, and coordinate data transfers and integration across EDC, diagnostic devices, central laboratories, and issue/discrepancy tracking systems.
• Review data for completeness, accuracy, consistency, and protocol compliance; investigate and resolve discrepancies with Clinical Operations, R&D, laboratory teams, and external partners.
• Partner with Biostatistics and Clinical teams to deliver clean, validated datasets on schedule; communicate data-quality metrics, outstanding queries, risks, and database-lock readiness in data review meetings.
• Serve as the data-management contact for CROs, central laboratories, EDC providers, and other vendors; review plans, specifications, transfer schedules, and deliverables, monitor quality and timelines, and escalate risks with recommended corrective actions.
• Support compliance with GCP, ICH E6, FDA 21 CFR Part 11, HIPAA, and other applicable requirements, including internal audits, quality reviews, regulatory inspections, and data-related responses.
• Prepare data and supporting documentation for FDA and other global regulatory submissions, ensuring reproducibility and traceability of data supporting diagnostic-product claims and filings.
• Develop and improve SOPs, work instructions, templates, and standardized practices to strengthen data quality, efficiency, scalability, and automation.
• Balance multiple studies and competing priorities in a fast-paced environment.

What You Will Bring

Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Biomedical Sciences, Biostatistics, Data Science, Health Informatics, or a related discipline.
• 5+ years of clinical data management experience in the medical device, diagnostics/IVD, biotechnology, or pharmaceutical industry.
• Hands-on experience managing clinical study data from study start-up through database lock.
• Demonstrated experience with EDC systems, eCRF design, edit checks, query management, data cleaning, reconciliation, and database quality control.
• Experience working with external data sources such as central laboratories, diagnostic instruments, CROs, or third-party vendors.
• Working knowledge of GCP and regulated clinical-data practices.
• Experience preparing clinical data for statistical analysis and/or regulatory submissions.
• Strong attention to detail and demonstrated commitment to data integrity and quality.
• Strong written and verbal communication skills with the ability to work effectively across technical and non-technical teams.
• Ability to manage multiple studies, priorities, and deadlines with limited supervision.

Preferred Qualifications

• Master's degree in a scientific, clinical, data, or quantitative field.
• Experience in diagnostics, in vitro diagnostics (IVD), or medical devices strongly preferred.
• Experience supporting clinical studies used for FDA 510(k), De Novo, PMA, or other regulatory submissions.
• Experience with platforms such as Medidata Rave, REDCap, Veeva Vault CDMS, or comparable EDC/CDMS systems.
• Working knowledge of CDISC/SDTM standards.
• Experience with SQL or relational databases.
• Familiarity with SAS, R, Python, Analyse-it or other statistical/data-processing tools.
• Experience developing clinical data-management SOPs and standardized processes.
• CCDM certification through the Society for Clinical Data Management is a plus.