Senior Clinical Trial Manager

MyOme, Inc.; San Francisco (CA); Remote; USD 145.000 - 185.000; Vollzeit

Benefits dieser Stelle

Healthcare (medical, dental, vision)

401K

Unlimited PTO

Professional development opportunities

Company-sponsored off-sites and team交流

Career growth and leadership access

Zusammenfassung

MyOme, Inc. is seeking a Senior Clinical Trial Manager to drive clinical evidence generation, manage studies through CROs, and ensure on-time, on-budget delivery of analysis-ready datasets.

This remote US role partners across internal teams and external vendors to translate evidence needs into robust protocols and SOPs. You will oversee study budgets, regulatory compliance, and risk management while coordinating cross-functional teams and ensuring high-quality results.

Qualifikationen

• 8+ years of clinical trial management experience
• 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 primary 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
• PMP certification preferred; willingness to travel up to 20%

Aufgaben

• Own study execution within timelines and budget, ensuring GCP and regulatory compliance
• Leads execution from feasibility to delivery of analysis-ready datasets
• Leads CROs and vendor selection for study execution
• Primary point of contact for vendors involved in study execution
• Oversees study budgets, reviews vendor invoices, tracks spend vs. plan
• Contributes to study documents: protocols, informed consent forms, lab manuals, monitoring plans, training materials and SOPs
• Leads cross-functional study team and escalates issues to management as needed
• Leads cross-functional risk review to identify and manage operational risks
• Collaborates with stakeholders across MyOme and provides progress updates

Kenntnisse

Clinical trial management

Vendor management

Budget management

Cross-functional leadership

Regulatory knowledge (FDA/GCP)

PMP certification

Communication

Travel readiness

Ausbildung

Bachelor’s degree in life science or related field

Advanced degree preferred (MS/MPH/MSN/PharmD/PhD)

Jobbeschreibung

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. Our team is composed of seasoned entrepreneurs, scientists, and operators, and we’re backed by top‑tier investors.

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 Need

• 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 USD - $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

Diversity, Inclusion, and Equal Opportunity

MyOme values diversity in all forms. We believe that diverse perspectives drive better science and better patient outcomes. We are an Equal Opportunity Employer committed to creating an inclusive workplace that empowers every individual.

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