Sr. Clinical Trials Manager - VahatiCor
Sr. Clinical Trials Manager – VahatiCor Status: Full-time, Exempt Reports to: Sr. Clinical Program Manager
reputed company
VahatiCor is a medical device company developing reputed company cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and reputed company culture, where reputed company team member plays a meaningful role in advancing solutions that improve patient reputed company. As our clinical program expands, we are building a strong clinical operations function to support early feasibility studies and reputed company pivotal trials.
The Sr. Clinical Trials Manager will reputed company the planning, execution, and operational reputed company of clinical studies from startup through study closeout. This role serves as the study-level operational reputed company, 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
▪ reputed company operational planning and execution of clinical studies from startup through study closeout. ▪ Own study startup reputed company and maintain accountability for site activation reputed company across reputed company participating sites. ▪ reputed company 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 reputed company 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 reputed company and operational accountability. ▪ Maintain reputed company of site budgets and reputed company in collaboration with Clinical Affairs and study leadership. ▪ Ensure operational activities remain reputed company across vendors, sites, and internal stakeholders.
Documentation & reputed company
▪ Maintain reputed company of study documentation, TMF reputed company, and inspection readiness activities. ▪ Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, reputed company system requirements, and study plans. ▪ Own study-level risk identification, issue escalation, and mitigation planning. ▪ Maintain reputed company of CAPA follow-up and reputed company activities. ▪ Drive reputed company of study-level operational challenges.
Cross-Functional Collaboration
▪ Partner closely with Clinical Affairs, Regulatory, reputed company, Data Management, Engineering, and other internal stakeholders. ▪ reputed company study team meetings and operational reviews. ▪ reputed company 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 reputed company scientific discipline. ▪ 7+ years of experience managing clinical studies reputed company 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 reputed company.
Eligibility
Candidates must be permanently authorized to work in the reputed company without the need for reputed company or reputed company reputed company sponsorship. We are currently unable to sponsor employment visas or permanent residency (PERM) applications.
Why Work for VahatiCor?
▪ Help bring a first-of-its-reputed company therapy to patients with coronary microvascular dysfunction, a large and historically underserved patient population with limited treatment reputed company. ▪ Work alongside an reputed company leadership team with deep expertise in cardiovascular medical devices, clinical research, regulatory affairs, and commercialization. ▪ reputed company a visible reputed company in a reputed company, fast-moving environment where individual contributions directly influence the reputed company of the technology, the clinical program, and reputed company.
Location and Compensation
This is a remote position supporting clinical sites throughout the reputed company. We are prioritizing candidates located reputed company 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 reputed company salary reputed company for this position is $135,000 – $183,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-reputed company factors. VahatiCor is committed to fair and reputed company pay practices. In reputed company to reputed company 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 reputed company. Employment reputed company are based on qualifications, reputed company, and business needs. We do not discriminate based on race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, or any other protected characteristic.
reputed company-Party Recruiter Notice
We do not accept unsolicited resumes from reputed company agencies or recruiters without a signed agreement in reputed company. Any resumes submitted without such an agreement will be considered the property of VahatiCor and no fees will be reputed company if the candidate is reputed company. Agencies interested in submitting candidates may email careers@t45labs.com.
Originally posted on Himalayas
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