Sr. Clinical Trials Manager - VahatiCor at T45 Labs

Santa Clara, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

183000.0

Posted On

13 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Vendor Management, Study Startup, Enrollment Forecasting, Risk Management, Budget Management, GCP Compliance, FDA Regulations, TMF Quality, Cross-functional Leadership, Cardiovascular Device Experience, Clinical Operations

Industry

Medical Equipment Manufacturing

Description

Sr. Clinical Trials Manager – VahatiCor Status: Full-time, Exempt Reports to: Sr. Clinical Program Manager 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 studies and future pivotal trials. The Sr. Clinical Trials Manager will lead the planning, execution, and operational oversight of clinical studies from startup through study closeout. This role serves as the study-level operational owner, accountable for timelines, budgets, vendor performance, enrollment forecasting, study metrics, risk management, and cross-functional execution. The ideal candidate brings deep experience in clinical operations leadership, study management, and cardiovascular medical device studies. Responsibilities Study Planning & Execution ▪ Lead operational planning and execution of clinical studies from startup through study closeout. ▪ Own study startup strategy and maintain accountability for site activation progress across all participating sites. ▪ Develop and maintain study timelines, milestones, and operational deliverables. ▪ Own enrollment forecasting, study metrics, and operational reporting. ▪ Identify operational risks and implement mitigation plans to maintain study performance. ▪ Ensure study execution remains aligned with protocol requirements, timelines, budgets, and business objectives. Vendor & Operational Management ▪ Serve as the primary operational contact for CROs, vendors, consultants, and external study partners. ▪ Manage vendor deliverables, timelines, communication, budgets, and performance. ▪ Own study-level vendor oversight and operational accountability. ▪ Maintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadership. ▪ Ensure operational activities remain aligned across vendors, sites, and internal stakeholders. Documentation & Quality ▪ Maintain oversight of study documentation, TMF quality, and inspection readiness activities. ▪ Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plans. ▪ Own study-level risk identification, issue escalation, and mitigation planning. ▪ Maintain oversight of CAPA follow-up and resolution activities. ▪ Drive resolution of study-level operational challenges. Cross-Functional Collaboration ▪ Partner closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholders. ▪ Lead study team meetings and operational reviews. ▪ Provide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadership. ▪ Drive alignment across internal teams, vendors, and clinical sites. ▪ Ensure consistent execution of study processes across participating sites. Required Experience & Qualifications ▪ Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline. ▪ 7+ years of experience managing clinical studies within the medical device industry. ▪ Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred. ▪ Demonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution. ▪ Demonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendors. ▪ Demonstrated experience overseeing clinical studies from startup through study closeout. ▪ Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations. ▪ Strong leadership, communication, organizational, and problem-solving skills. ▪ Ability and willingness to travel up to 30% based on study and business needs. ▪ Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to success. 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. Why Work for VahatiCor? ▪ Help bring a first-of-its-kind therapy to patients with coronary microvascular dysfunction, a large and historically underserved patient population with limited treatment options. ▪ Work alongside an experienced leadership team with deep expertise in cardiovascular medical devices, clinical research, regulatory affairs, and commercialization. ▪ Make a visible impact in a collaborative, fast-moving environment where individual contributions directly influence the future of the technology, the clinical program, and the company. Location and Compensation This is a remote position supporting clinical sites throughout the United States. We are prioritizing candidates located within reasonable proximity to a major airport to support travel requirements. Travel of up to 30% is required based on study and business needs. The anticipated annual base salary range for this position is $135,000 – $183,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. VahatiCor is committed to fair and equitable pay practices. In addition to base salary, the total compensation package may include bonus opportunities, equity, and company-sponsored benefits. 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@t45labs.com.

Responsibilities

Lead the operational planning, execution, and oversight of cardiovascular medical device clinical studies from startup through closeout. Manage CROs, vendors, and internal stakeholders while ensuring compliance with FDA regulations and GCP.