Senior Clinical Trials Manager VahatiCor

Draft Job Description:

Title: Senior Clinical Trials Manager - VahatiCor

Status: Full-time Exempt

Reports to: VP of Clinical Affairs - VahatiCor

Overview

VahatiCor is a medical device startup developing breakthrough cardiovascular technologies including Class III catheter-based systems. We operate with a purpose-driven agile and collaborative culture where every team member contributes to advancing solutions that improve patient outcomes. We embrace the urgency of a startup environment while maintaining the highest standards of quality and compliance.

About the Role

The Senior Clinical Trials Manager plays a central role in the planning execution and management of clinical studies supporting VahatiCors cardiovascular technology portfolio. This individual will provide hands-on oversight of day-to-day clinical trial operations ensuring studies are conducted in compliance with regulatory requirements timelines and budgets. The role requires strong operational expertise attention to detail proactive problem solving and the ability to collaborate effectively across internal departments and external partners. The Senior Clinical Trials Manager will partner closely with the VP of Clinical Affairs to support strategic execution of early feasibility pilot and pivotal trials.

Responsibilities

Study Planning & Execution

Manage the operational planning and execution of clinical studies including start-up enrollment monitoring and close-out activities.

Oversee site readiness activities such as feasibility assessments site selection activation and training.

Track enrollment progress site performance subject compliance data quality and study metrics; identify risks and implement corrective actions as needed.

Coordinate the development review and maintenance of essential study documents including protocols informed consent forms monitoring plans and site tools.

Support investigational product logistics including accountability reconciliation and returns.

Vendor & CRO Collaboration

Serve as the primary operational contact for CROs vendors and consultants.

Manage deliverables timelines and communication to ensure high-quality execution.

Review vendor budgets contracts and performance metrics; escalate issues as needed.

Clinical Monitoring Oversight

Provide oversight of study monitors including review of monitoring visit reports action item follow-up and issue resolution.

Ensure monitoring activities are conducted per study plans SOPs and regulatory requirements.

Support the development and refinement of monitoring tools and processes.

Documentation & Systems

Ensure the Trial Master File (TMF) is complete inspection-ready and maintained in accordance with company procedures and regulatory standards.

Review and reconcile site documentation logs and essential regulatory files.

Support eCRF review query management and data-cleaning activities in collaboration with data management.

Cross-Functional Collaboration

Work closely with Clinical Affairs Regulatory Quality and R&D to align trial operations with program needs.

Participate in protocol development study planning meetings and team reviews.

Provide study updates operational insights and risk mitigation recommendations.

Training & Site Support

Deliver training to study sites field teams and internal stakeholders as needed.

Respond promptly to site questions deviations and operational challenges.

Maintain strong collaborative relationships with investigators and site personnel.

Required Experience and Qualifications

Bachelors degree in life sciences or related field.

68 years of experience in clinical research or clinical operations including direct experience managing clinical trials in the medical device industry.

Experience supporting early feasibility pilot or pivotal device trials (cardiovascular preferred).

Solid understanding of FDA regulations ICH/GCP guidelines and ISO 14155.

Experience collaborating with CROs vendors and clinical research sites.

Strong organizational and communication skills with the ability to manage multiple tasks and deadlines.

Proactive problem-solving skills with proven ability to drive study progress.

Ability to travel up to 25%.

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.

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 $157000 - $213000 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 legally protected status.

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 property of VahatiCor and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles please email

Required Experience:

Manager