Clinical Trials Manager VahatiCor

JD:

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.

Vendor & Site Support

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.

Documentation & Quality Oversight

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.

Cross-Functional Coordination

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.

Required Experience & Qualifications

Bachelors degree in the life sciences or a related field.

Minimum 35 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 2030%).

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 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 $133000 - $179000 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

Required Experience:

Manager