Job Description

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 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

Key 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
  
  

Required Experience and Qualifications

• Bachelors 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
  
  

Preferred Qualifications

• 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
  
  
  

What Were Looking For

• A hands-on data manager who takes ownership of data quality and keeps studies moving
  
  
• Strong attention to detail with the ability to identify inconsistencies and resolve issues proactively
  
  
• Comfortable working across multiple studies and shifting priorities in a fast-paced start-up environment
  
  
• Able to work independently while collaborating closely with Clinical Operations Biostatistics and external partners
  
• Practical execution-focused and responsive to the needs of evolving clinical programs.

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 $117000 - $159000 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

Required Experience:

Manager

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