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MyOme

Senior Clinical Trial Manager

RemoteUnited States only
Published
Experience
Lead
Company size
Startup
$145k–$185k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior Clinical Trial Manager needed with 8+ years of experience, including 5+ years managing IVD clinical studies. Must have substantial experience managing CROs and vendors for large, multi-site studies, with strong knowledge of FDA regulations and GCP. Requires a life science degree and proven ability to manage budgets, timelines, and cross-functional teams with minimal oversight. Experience with interventional diagnostic or cancer early detection studies preferred.

Required skills

Good Clinical PracticeFDA regulation

Optional skills

PMP certification

Required languages

English

What you'll do

  • Own study execution within agreed upon timelines and budget, ensuring compliance with Good Clinical Practice, applicable regulatory requirements, study protocols and MyOme SOPs.
  • Leads the execution of studies from feasibility to delivery of analysis-ready datasets.
  • Leads the identification and selection process for CROs and other vendors supporting study execution.
  • Primary point of contact for vendors involved in study execution.
  • Oversees study budgets, reviewing and approving vendor invoices, tracking spend versus plan in partnership with Accounting and Finance
  • Contributes to the development of study-related documents including protocols, informed consent forms, laboratory manuals, monitoring plans, communication plans, training materials and SOPs
  • Leads the internal, cross-functional study team and acts as the driver for escalation of issues to MyOme management that may impact study delivery on-time and on-budget.
  • Leads the cross-functional study risk review process, proactively identifying and managing operational risks.
  • Collaborates with key stakeholders across MyOme and provides periodic updates on study progress

What they require

  • Bachelor’s degree in a life science, health-discipline or related field.
  • Advanced degree (e.g., MS, MPH, MSN, PharmD, PhD) preferred.
  • A minimum of 8 years of clinical trial management experience, with at least 5 years running IVD clinical studies
  • Experience with interventional diagnostic studies and/or cancer early detection studies preferred.
  • Experience managing large (5,000+ participant) studies preferred.
  • Demonstrated success managing CROs and other clinical study vendors as the primary point of accountability on large, multi-site studies.
  • Strong working knowledge of FDA regulation and Good Clinical Practice guidelines for diagnostic studies.
  • Strong analytical, problem-solving, communication, and stakeholder management skills.
  • Proven ability to manage study budgets, timelines and cross-functional teams with minimal oversight,
  • Excellent communication, negotiation and stakeholder management skills.
  • Willingness to travel up to 20%

Benefits

  • Comprehensive healthcare coverage (Health, Dental, and Vision)
  • 401K
  • Unlimited PTO
  • Professional development opportunities
  • Company-sponsored off-sites and team meals during in-person meetings
  • Direct access to company leadership and the opportunity for career growth

MyOme’s mission is to provide clinically actionable genetic information to patients throughout their lives. We combine clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results.

HealthcareStartup
$145k–$185k/yr