[Remote] Sr. Clinical Trials Manager - VahatiCor

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.ResponsibilitiesLead operational planning and execution of clinical studies from startup through study closeoutOwn study startup strategy and maintain accountability for site activation progress across all participating sitesDevelop and maintain study timelines, milestones, and operational deliverablesOwn enrollment forecasting, study metrics, and operational reportingIdentify operational risks and implement mitigation plans to maintain study performanceEnsure study execution remains aligned with protocol requirements, timelines, budgets, and business objectivesServe as the primary operational contact for CROs, vendors, consultants, and external study partnersManage vendor deliverables, timelines, communication, budgets, and performanceOwn study-level vendor oversight and operational accountabilityMaintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadershipEnsure operational activities remain aligned across vendors, sites, and internal stakeholdersMaintain oversight of study documentation, TMF quality, and inspection readiness activitiesEnsure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plansOwn study-level risk identification, issue escalation, and mitigation planningMaintain oversight of CAPA follow-up and resolution activitiesDrive resolution of study-level operational challengesPartner closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholdersLead study team meetings and operational reviewsProvide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadershipDrive alignment across internal teams, vendors, and clinical sitesEnsure consistent execution of study processes across participating sitesSkillsBachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline7+ years of experience managing clinical studies within the medical device industryDemonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional executionDemonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendorsDemonstrated experience overseeing clinical studies from startup through study closeoutDemonstrated understanding of FDA regulations, ICH/GCP, and clinical research operationsStrong leadership, communication, organizational, and problem-solving skillsAbility and willingness to travel up to 30% based on study and business needsThrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to successExperience with cardiovascular and catheter-based medical device clinical studies strongly preferredBenefitsBonus opportunitiesEquityCompany-sponsored benefitsCompany OverviewT45 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/.