Job Description

Job Description

Job Description

Clinical Data Manager – T45 Labs

Status: Full-time, Exempt

Location: Onsite, Santa Clara, CA

Reports to: Sr. Clinical Trials Manager

About the Company

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.

About the Role

We are seeking a Clinical Data Manager to lead study-level data management activities across multiple medical device clinical studies.

This is a hands-on role responsible for building, configuring, and managing clinical study databases and associated data management processes from study startup through database lock. You will work closely with Clinical Operations, Biostatistics, CROs, and external vendors to ensure accurate, high-quality, audit-ready clinical data.

The ideal candidate has experience building EDC databases from protocol, designing CRFs/eCRFs, developing edit checks, leading user acceptance testing (UAT), and managing clinical data throughout the study lifecycle. This role requires a high degree of independence, ownership, and execution in a fast-paced startup environment.

Key Responsibilities

• Develop and maintain Data Management Plans (DMPs) across clinical studies
  Design Case Report Forms (CRFs/eCRFs) aligned with study protocols
• Build, configure, and maintain study databases within Electronic Data Capture (EDC) systems
• Develop and review edit checks, validation rules, and data review plans
• Lead User Acceptance Testing (UAT) and database validation activities prior to study launch
• Develop and manage data transfer specifications and external vendor data integrations
• Perform ongoing data cleaning, validation, discrepancy management, and query resolution
• Conduct regular data review and reconciliation activities to maintain database integrity
• Lead study-level database lock activities, including query closure, reconciliation, and documentation review
• Partner with Clinical Operations, Biostatistics, Regulatory, CROs, and external vendors to ensure data quality and compliance
• Provide data listings, reports, and study metrics to support clinical teams
• Build and maintain study trackers using Excel, Smartsheet, or similar tools
• Support inspection readiness and regulatory submission activities
• Identify opportunities to improve data quality, efficiency, and study execution
  

Required Experience and Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field
• 5+ years of clinical data management experience within medical device, biotechnology, pharmaceutical, or CRO environments
• Hands-on experience building and configuring EDC databases from protocol through study launch
• Experience designing CRFs/eCRFs, edit checks, validation rules, and data review workflows
• Experience leading UAT and database validation activities
• Strong knowledge of GCP, FDA, ICH, and applicable clinical data management regulations
• Experience with data cleaning, query management, reconciliation, and database lock activities
• Experience working with CROs, external vendors, and cross-functional study teams
• Strong analytical and problem-solving skills with exceptional attention to detail
• Ability to work independently and manage multiple priorities in a fast-paced startup environment
• Proficiency with Excel and/or Smartsheet for study tracking and reporting

Preferred Qualifications

• Experience supporting cardiovascular, vascular, or catheter-based medical device studies
• Experience serving as the lead data manager for a clinical study or program
• Experience supporting global, multi-site clinical studies
• Familiarity with data visualization and reporting tools such as Power BI, Tableau, Spotfire, or JMP
  Experience supporting early feasibility, first-in-human, and pivotal clinical studies

What We're Looking For

• A hands-on Clinical Data Manager who can independently lead study-level data management activities from startup through database lock
• Strong technical understanding of EDC database build, validation, and study startup activities
• Comfortable operating with a high degree of ownership and accountability
• Able to balance attention to detail with execution against aggressive timelines
• Collaborative, practical, and responsive in a fast-paced startup environment
• Committed to delivering high-quality, audit-ready clinical data that supports successful clinical and regulatory outcomes

Eligibility

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas, or permanent residency (PERM) applications.

Location and Compensation

This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available.

T45 Labs is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.

Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired.

The anticipated salary range of this position is $117,000 - $159,000 annually, based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired. Most candidates should expect to receive an offer around the mid-point of the posted range, based on these considerations.

Equal Employment Opportunity

T45 Labs is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Third-Party Recruiter Notice

T45 Labs does not accept unsolicited resumes from agencies. Any resumes submitted without a signed agreement will be considered the property of T45 Labs and no fees will be paid. Agencies interested in submitting candidates may email careers@t45labs.com

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