Senior Clinical Ops Lead – Phase 1-3 (Remote)

Travere Therapeutics; Columbus (OH); Hybrid; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics is seeking a Senior Manager, Clinical Operations to lead and oversee Phase 1–3 trials, coordinating internal teams, CROs, and sites to ensure timely study delivery. You will manage timelines, budgets, and cross-functional activities, while ensuring compliance with ICH/GCP and regulatory standards.

The role requires a strong background in clinical operations, site management, and vendor oversight, with the ability to travel domestically and internationally (about 10–20%).

Qualifications

• Bachelor's degree or equivalent combination of education and applicable job experience.
• 7+ years of clinical trial experience with 2+ years of managing clinical studies at a sponsor or CRO.
• Experience in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH E6 (R2) GCP.
• Phase 1-3 study experience or relevant experience including international studies is preferred.

Responsibilities

• Manage daily oversight of internal study teams, CROs, sites and vendors to ensure trial execution.
• Triage, resolve, or elevate study issues to Clinical Operations Management.
• Ensure on-time delivery of study milestones and manage study budgets/timelines.
• Guide Biometrics, PV and others to ensure study execution per SOPs and ICH/GCP.
• Track study status, enrollment, regulatory documents, and site start-up.

Skills

Communication skills

Problem-solving

Attention to detail

Cross-functional collaboration

Project management

Education

Bachelor's degree or equivalent combination of education and applicable job experience

Tools

MS Office

MS Project

Smartsheet

IRT systems

eTMF

Job description

Travere Therapeutics is seeking a Senior Manager, Clinical Operations to lead and oversee Phase 1–3 trials, coordinating internal teams, CROs, and sites to ensure timely study delivery. You will manage timelines, budgets, and cross-functional activities, while ensuring compliance with ICH/GCP and regulatory standards.

The role requires a strong background in clinical operations, site management, and vendor oversight, with the ability to travel domestically and internationally (about 10–20%).