Clinical Data Manager T45 Labs
Job Location:
Santa Clara County, CA - USA
Yearly Salary:
Posted on:
Vacancies:
Job Summary
Clinical Data Manager T45 Labs
Status: Full-time Exempt
Location: Onsite Santa Clara CA
Reports to: Sr. Clinical Trials Manager
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 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
- Bachelors 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 Were 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 $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
