Director, Clinical Data Management & Data Science

Position Overview

Truvian is a fast-paced, disruptive healthcare company revolutionizing blood testing with its automated, benchtop diagnostic system. As the Director, Clinical Data Management & Data Science, you will build and lead a multidisciplinary team responsible for the clinical data strategy, management, analytics, and statistical sciences throughout the product lifecycle. This ONSITE role is central to ensuring data integrity, regulatory compliance, and operational efficiency in a highly regulated environment.

Key Responsibilities

• Develop and execute a unified, robust, and scalable data strategy to support clinical trials, R&D studies, and regulatory submissions.
• Build and mentor a high-performing team of data managers, database programmers, biostatisticians, and data scientists.
• Serve as a senior advisor to Clinical, R&D, and Regulatory leaders on data architecture, analytics, and evidence strategies.
• Ensure alignment of data architecture with business goals and regulatory requirements.
• Lead the design, integration, and governance of clinical databases and data pipelines.
• Oversee the implementation and validation of EDC systems, LIMS, and data warehouse tools.
• Guide the creation of user-friendly tools for data input, extraction, and analysis.
• Ensure compliance with 21 CFR Part 11, GCP, HIPAA, and other applicable regulations.
• Establish SOPs, standards, and templates for data collection, cleaning, reconciliation, and database lock.
• Direct data management activities for clinical studies ensuring data quality, completeness, and traceability.
• Collaborate with CRO partners and central labs to ensure consistent data flow and integrity.
• Provide strategic direction for statistical design, analysis, and interpretation of clinical studies.
• Oversee the development of statistical analysis plans (SAPs) ensuring robust model validation.
• Guide exploratory and confirmatory data analyses using both traditional biostatistics and modern data science/ML techniques.
• Drive the development of data visualization dashboards and analytic tools for real-time decision-making.
• Partner with Clinical Operations, Regulatory Affairs, Quality, and Product Development teams to align data strategy with business goals.
• Support regulatory submissions through clear, validated, and reproducible data outputs.
• Translate complex data analyses into compelling narratives for scientific and regulatory audiences.

Required Qualifications

• Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or a related quantitative field.
• Minimum of 10 years of experience in clinical data management, biostatistics, or data science within diagnostics, medical devices, or pharmaceuticals.
• Minimum of 5 years of management and leadership experience.
• Proven experience building and leading data teams in a regulated environment.
• Demonstrated ability to design and integrate clinical databases and data pipelines.
• Strong command of SQL and relational databases (e.g., PostgreSQL, MS SQL Server).
• Deep understanding of FDA regulations including 21 CFR Part 11, Part 820, GCP, and ICH E6.
• Familiarity with EDC systems, data visualization tools, and data standards (e.g., CDISC/SDTM, HL7/FHIR).
• An analytical mindset with strong attention to detail.
• Proactive, self-motivated, and ownership driven.
• Exceptional communication skills for technical and non-technical audiences.
• Ability to thrive in a fast-paced, start-up environment.

Preferred Qualifications

• Knowledge of cloud platforms (AWS, Azure) and data governance frameworks.
• Startup or small-company experience building infrastructure from scratch.
• Prior experience supporting FDA submission data requirements for IVDs (e.g., 510(k), PMA, EUA).

Benefits & Perks

• Unique Growth Opportunity to gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development.
• Data-Driven Innovation: Contribute to real-world healthcare solutions backed by rigorous data.
• Fast-Paced Start-Up Culture with immediate impact and minimal red tape.
• Professional Development through mentorship and continuous learning.
• Meaningful Impact by bringing innovative diagnostic products to market.
• Enjoy perks such as Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), Flexible Vacation, kombucha, cold brew, craft coffee, and a variety of healthy snacks.
• Compensation: Salary range of $196,000 - $216,000, determined by experience and qualifications.