Senior Clinical Trial Manager

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.

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%