Clinical Data Manager (Temp)

ABOUT Want to join a fast-paced, innovative company that is transforming the future of blood testing? Truvian is a healthcare technology company operating at the intersection of diagnostics and consumer technology. We have developed an automated benchtop diagnostic platform that delivers laboratory-quality results in minutes across a broad range of health tests.

Our proprietary, FDA-cleared technology is designed to make blood testing more accessible, convenient, and affordable by providing comprehensive results from a single small blood sample in minutes throughout a broad range of locations. We are continuing to advance our technology’s capabilities to further redefine point-of-care testing and bring high-quality healthcare closer to where patients need it most.

To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!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. The successful candidate possesses hands-on experience in the IVD or medical device industry, a solid understanding of FDA regulations (21 CFR Part 11, Part 820, GCP), and a proven record of rigorous data governance in regulated clinical environments. They will bring strong clinical data management fundamentals along with the ability to operate effectively in a fast-paced medical diagnostics environment.

Location and Work Arrangements Location: San Diego, CA (ONSITE Highly Preferred)

Visa Sponsorship Candidates must be authorized to work in the United States on a full-time basis. Truvian does not currently provide visa sponsorship or support employment-based immigration petitions for this role.

HERE’S WHY YOU’LL LOVE THIS JOB: • You will directly contribute to the development and validation of innovative diagnostic products intended to expand access to actionable health information.

• You will work with a collaborative, multidisciplinary team of assay scientists, chemists, engineers, data scientists, quality professionals, and manufacturing partners.
• You will gain hands-on experience across the product development lifecycle, from design and optimization through verification, validation, regulatory submission, and product support.
• You will thrive in a fast-paced, dynamic environment where thoughtful experimentation, rigorous documentation, and practical problem-solving make an immediate impact.
• You’ll have great perks such as:
• Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
• Flexible vacation
• Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
• Onsite gym
• Farm to table onsite restaurant including a 30% discount

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.

Key Competencies

• Clinical data integrity and attention to detail
• Technical aptitude
• Results-driven execution
• Problem solving and resiliency
• Accountability and ownership
• Cross-functional teamwork
• Adaptability in a fast-paced environment
• Strong time and priority management
• Clear and effective communication
• Quality and regulatory mindset

SUPERVISORY ROLE No direct supervisory responsibility; may provide training or technical guidance to junior team members.

COMPENSATION $123,000 to $136,000 The salary range for this position represents the anticipated range for qualified candidates. Compensation decisions are based on a variety of factors, including relevant experience, skills, education, training, certifications, internal equity, market data, and business needs. The final compensation offered to a successful candidate will be determined based on these factors and the requirements of the role.

PHYSICAL DEMANDS AND ABILITIES • Frequently required to sit or stand for extended periods and perform repetitive laboratory tasks requiring fine motor control.

• Specific vision abilities include close vision, color vision, depth perception, and the ability to adjust focus.

Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an opportunity to highlight how your experience in assay and/or panel architecture aligns with our mission, your approach to technical leadership and cross-functional collaboration, and how your expertise has driven innovation in diagnostic product development and complex assay systems.

Truvian is an Equal Opportunity Employer and is committed to fostering a diverse, inclusive, and respectful workplace. Employment decisions are made based on qualifications, merit, and business needs. Truvian prohibits discrimination, harassment, and retaliation and does not discriminate on the basis of any characteristic protected by applicable federal, state, or local law, including race, color, religion, creed, sex, pregnancy (including childbirth, breastfeeding, and related medical conditions), gender, gender identity, gender expression, sexual orientation, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, reproductive health decision-making, or any other legally protected status. This policy applies to all aspects of employment, including recruitment, hiring, placement, promotion, compensation, benefits, training, transfers, leaves of absence, disciplinary actions, termination, and all other terms and conditions of employment. Truvian is also committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, in accordance with applicable law.