Senior Clinical Trial Manager
- Location
- Remote
- Employment type
- unknown
- Posted
- Posted
- R&D/Lab
About the role
MyOme is a clinical whole genome analysis company helping individuals and families understand their risk for disease. As a leader in polygenic and AI-based integrative risk modeling, we combine genome sequencing with AI-driven analytics and clinical data to deliver a lifetime of clinically meaningful, actionable insights, from proactive risk assessment to rare disease diagnosis. Our laboratory is CLIA-certified and CAP-accredited, and we’re based in Menlo Park, California. Our team brings together scientists, engineers, clinicians, and professionals across disciplines, united by a shared purpose: making genomic insight a routine part of everyday healthcare. We put patients first and hold ourselves to the scientific and clinical rigor that families and their clinicians depend on. Joining MyOme means contributing your expertise to work that matters for patients and families. Whether you’re advancing our science and technology, supporting the clinicians and patients we serve, or strengthening our operations, you’ll help turn genomic discoveries into better care. Position Overview: The Senior Clinical Trial Manager is a key contributor to MyOme’s clinical evidence generation strategy with responsibility for executing assigned clinical studies within agreed upon timelines and budgets. This is a highly cross-functional role that partners closely with internal stakeholders and external partners to translate evidence needs into actionable clinical protocols and oversees their execution by CROs, supporting vendors, and study sites. You must have substantial experience successfully managing clinical studies through CROs. 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 You'll Ne ed: 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, PMP certification preferred. Excellent communication, negotiation and stakeholder management skills. Willingness to travel up to 20% Location, Compensation, and Benefits: Location: Remote in the US Compensation: Annual salary range is $145,000 - $185,000, based on experience. This role is also eligible for equity. San Francisco Bay Area pay range $145,000 — $185,000 USD 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 Equal Employment Opportunity and Reasonable Accommodations MyOme is an equal opportunity employer. We make employment decisions without regard to race, color, ancestry, national origin, religion, age, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, reproductive health decision-making, or any other characteristic protected by applicable law. MyOme provides reasonable accommodations to qualified applicants with disabilities and as otherwise required by law. To request an accommodation during the application or interview process, please contact hr@myome.com. Why Work at MyOme? Join us if you: Want to make an impact at the intersection of healthcare and technology, changing the way people engage with their health at the genetic level Enjoy rolling up your sleeves, taking initiative, and being empowered to lead Value humility, transparency, and collaborative problem-solving Thrive in fast-moving, dynamic environments with smart, driven teammates Appreciate competitive compensation, meaningful equity, and excellent benefits Learn More: myome.com
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