Clinical Data Manager - T45 Labs
About The Position
T45 Labs advances breakthrough cardiovascular technologies from early development into the clinic. We focus on selecting the right innovations, developing them with precision, and moving them through critical clinical and regulatory milestones so they reach the physicians and patients who need them most. We are seeking a Clinical Data Manager to lead data management activities across multiple medical device clinical programs. This is a hands-on role responsible for managing and maintaining clinical data systems to ensure accuracy, integrity, and usability of study data. You will work closely with Clinical Operations, Biostatistics, and external partners to support studies from early feasibility through pivotal trials. This role is well-suited for someone who is detail-oriented, technically strong, and comfortable operating in a fast-paced, start-up environment where priorities evolve and execution matters
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, or a related field
- 5+ years of experience in clinical data management, preferably in a medical device environment
- Hands-on experience with EDC systems and CRF configuration
- Strong knowledge of GCP, FDA, and ICH guidelines related to clinical data management
- Experience with data cleaning, query management, and database lock processes
- Strong analytical and problem-solving skills with high attention to detail
- Proficiency in Excel and/or Smartsheet for tracking and data organization
- Ability to work cross-functionally and manage multiple priorities in a fast-paced, start-up environment
Nice To Haves
- Experience supporting cardiovascular or catheter-based medical device studies
- Familiarity with EDC configuration and ongoing system management (not initial build)
- Familiarity with data visualization tools (e.g., Power BI, Tableau, Spotfire, JMP)
- Experience supporting early feasibility or first-in-human studies
Responsibilities
- Develop and maintain Data Management Plans (DMPs) across clinical studies
- Design Case Report Forms (CRFs) aligned with study protocols
- Configure and manage CRFs within Electronic Data Capture (EDC) systems
- Perform ongoing data cleaning, validation, and discrepancy management
- Generate, track, and resolve data queries; identify trends and inconsistencies
- Lead study-level database lock activities, including query closure and documentation review
- Conduct regular data review and reconciliation to maintain database integrity
- Partner with Clinical Operations, Biostatistics, and Regulatory teams to ensure data quality and compliance
- Provide data listings, reports, and study metrics to support clinical teams
- Build and maintain study trackers using Excel and/or Smartsheet to monitor progress and data quality
- Apply formulas, filters, and logic functions to ensure accuracy and visibility of study data
- Support process improvement initiatives to enhance data workflows and reporting
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
