What are the responsibilities and job description for the Clinical Trials Manager - VahatiCor position at T45 Labs?
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Title: Clinical Trials Manager - VahatiCor
Status: Full-time, Exempt
Reports to: Director of Clinical Affairs - VahatiCor
Overview
VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program expands, we are building a strong clinical operations function to support early feasibility and pivotal-stage device trials.
The Clinical Trials Manager (CTM) will support the planning, execution, and oversight of clinical studies, coordinating operational activities, managing timelines, and ensuring high-quality study conduct. This role requires strong organizational skills, a proactive mindset, and the ability to work effectively across sites, vendors, and internal teams. Experience in medtech is imperative.
Responsibilities
Study Planning & Execution
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 role is 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.
VahatiCor 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 $133,000 - $179,000 based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.
Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.
Equal Opportunity Statement
VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
Third-Party Recruiter Notice
We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email careers@vahaticor.com.
Title: Clinical Trials Manager - VahatiCor
Status: Full-time, Exempt
Reports to: Director of Clinical Affairs - VahatiCor
Overview
VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program expands, we are building a strong clinical operations function to support early feasibility and pivotal-stage device trials.
The Clinical Trials Manager (CTM) will support the planning, execution, and oversight of clinical studies, coordinating operational activities, managing timelines, and ensuring high-quality study conduct. This role requires strong organizational skills, a proactive mindset, and the ability to work effectively across sites, vendors, and internal teams. Experience in medtech is imperative.
Responsibilities
Study Planning & Execution
- Assist in the development of study plans, timelines, and operational deliverables
- Support site selection, study start-up activities, and regulatory submissions
- Coordinate study logistics, including vendor interactions, site communication, and document tracking
- Maintain trial master file (TMF) completeness and quality
- Monitor enrollment progress and site performance; identify issues and escalate as needed
- Track study milestones and ensure timely completion of deliverables
- Partner with CROs, central labs, imaging vendors, and other service providers to ensure aligned expectations and performance
- Review vendor reports and contribute to data quality oversight
- Support investigational product accountability and reconciliation processes
- Participate in study meetings and provide follow-up on action items
- Assist in drafting or reviewing study tools, manuals, site materials, and operational documents
- Ensure consistency with SOPs, GCP, FDA regulations, and quality system requirements
- Support inspection readiness by maintaining accurate, audit-ready documentation
- Help manage study-level risk logs, issue tracking, and CAPA follow-up
- Collaborate with data management, clinical leadership, regulatory, quality, and engineering teams to ensure cohesive trial execution
- Support data review meetings and contribute to operational insights
- Facilitate communication across internal stakeholders and study sites
- Bachelor's degree in the life sciences or a related field
- Minimum 3-5 years of clinical research experience within the medtech industry; device or cardiovascular experience strongly preferred
- Experience supporting or coordinating clinical trials at the sponsor or CRO level
- Strong understanding of FDA regulations, ICH/GCP, and clinical trial processes
- Excellent communication, organization, and problem-solving skills
- Ability to manage multiple priorities in a fast-paced environment
- Ability to travel as needed (approximately 20-30%)
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 role is 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.
VahatiCor 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 $133,000 - $179,000 based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.
Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.
Equal Opportunity Statement
VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
Third-Party Recruiter Notice
We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email careers@vahaticor.com.
Salary : $133,000 - $179,000