Note: The job is a remote job and is open to candidates in USA. VahatiCor is a medical device company focused on developing innovative cardiovascular technologies. They are seeking a Sr. Clinical Trials Manager to lead the planning, execution, and oversight of clinical studies, ensuring alignment with timelines, budgets, and regulatory requirements.
Responsibilities
- 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
- 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
- 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
- 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
Skills
- 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
- 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
- Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred
Benefits
- Bonus opportunities
- Equity
- Company-sponsored benefits
Company Overview
T45 Labs is a med-tech incubator that specializes in developing minimally invasive technologies for the cardiovascular market. It was founded in 2022, and is headquartered in Santa Clara, California, USA, with a workforce of 11-50 employees. Its website is https://t45labs.com/.