Senior Clinical Operations Lead - Remote (Phase 1-3)

Travere Therapeutics; United States; On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

401k/retirement plan

Generous paid time off

Job summary

Travere Therapeutics in San Diego, CA, seeks a Senior Manager, Clinical Operations to supervise and execute Phase 1–3 clinical operations. You will coordinate daily activities with internal teams, CROs, and sites to support trial activities and on‑time delivery of milestones.

The role requires 7+ years in clinical trials, regulatory knowledge (US CFR, EU CTD, ICH E6), and the ability to lead cross‑functional teams. Travel up to 20% domestically and internationally; onsite in San Diego.

Qualifications

• Bachelor’s degree or equivalent combination of education and applicable job experience may be considered.
• 7+ years of clinical trial experience required with 2+ years of experience 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 and provide daily oversight of internal study teams, full-service CROs, clinical sites and third‑party vendors to ensure successful clinical trial implementation and execution.
• Triage, resolve, or elevate study issues to Clinical Operations Management.
• Evaluate a variety of unpredictable scenarios and achieve project timelines while applying understanding of study protocols.
• Manage entirety of assigned area or study(ies) (i.e. program timeline, budgets, study management team) and ensure on‑time delivery of study milestones.
• Guide other functional activities including Biometrics, PV, and others to ensure study execution in compliance with SOPs and ICH/GCP.
• Track study status, timelines, enrollment, regulatory documentation, and site start‑up status for assigned trials.
• Develop and/or provide input into clinical study documents (protocols, ICF templates, study plans/tools, site budgets, recruitment material).
• Oversee current CRO/vendor budgets and track/forecast changes with Strategic Procurement.
• Track and manage trial‑related materials/supplies and laboratory samples.
• Lead cross‑functional activities to establish SMT goals and communicate issues and mitigations.
• Provide basic strategic input into areas of study management.
• Additional duties assigned as needed.

Skills

MS Office

MS Project

Smartsheet

Timeline management

Communication skills

Problem solving

Travel willingness

Education

Bachelor's degree or equivalent

Tools

IRT

eTMF

Job description

Travere Therapeutics in San Diego, CA, seeks a Senior Manager, Clinical Operations to supervise and execute Phase 1–3 clinical operations. You will coordinate daily activities with internal teams, CROs, and sites to support trial activities and on‑time delivery of milestones.

The role requires 7+ years in clinical trials, regulatory knowledge (US CFR, EU CTD, ICH E6), and the ability to lead cross‑functional teams. Travel up to 20% domestically and internationally; onsite in San Diego.