Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company focused on identifying, developing, and delivering therapies for people living with rare diseases. The Senior Manager, Clinical Operations oversees the execution of Phase 1–3 clinical trials, coordinating internal teams, CROs, clinical sites, and vendors. The role manages study timelines, budgets, documentation, compliance, and cross-functional activities to ensure successful trial delivery.
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 escalate study issues to Clinical Operations Management
- Evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply understanding of study protocol(s)
- Manage entirety of assigned area or study(ies) (i.e. program timeline, budgets, study management team [SMT]) and is responsible for on-time delivery of study milestones
- Guide other functional activities including Biometrics, PV, and others to ensure clinical study execution in compliance with study plans, SOPs, and ICH/GCP
- Track study status, timelines, enrollment, regulatory documentation, and site start‐up status (as applicable) for assigned clinical trials
- Develop and/or provide input into clinical study documents (e.g., clinical study protocol, ICF templates, study plans/tools, and site-facing materials such as site budgets, recruitment material, etc.)
- Oversee current CRO/vendor budgets and tracks/forecast changes in conjunction with Strategic Procurement
- Track and manage trial-related materials/supplies and laboratory samples
- Independently leads cross functional activities in establishing and meeting SMT goals and communicate key issues and mitigations to relevant cross-functional stakeholders
- Provide basic strategic input into areas of study management
- Additional duties assigned as needed
Skills
- 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 but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork
- Driven, intelligent, passionate about making a difference for patients with rare diseases
- Proactive, self-starter who possesses the desire to take on additional tasks (in and out of Clinical Operations)
- Ability to establish goals for assigned studies and execute within an established timeframe
- Ability to independently identify issues, determine cause, and propose/implement solutions
- Proficient communication skills, both oral and written with ability to present study updates at various cross-functional meetings
- Advanced problem-solving skills and critical thinking skills
- Strong sense of urgency, keen attention to detail, and ability to work independently
- Strong skills in MS Office and timeline software such as MS Project or Smartsheet. Experience with clinical systems such as IRT, eTMF, etc
- Successful record of creating and managing complex project plans, timelines, budgets, and critical paths
- Well organized and can effectively oversee priorities/assigned study(ies) under time and resource pressures
- Demonstrates excellent understanding of cross functional activities and input into clinical studies
- Ability to travel 10-20% domestically and internationally
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote
- Phase 1 -3 study experience or relevant experience including international studies is preferred
Benefits
- Premium health offerings for eligible employees and dependents
- Financial offerings for eligible employees and dependents
- Work-life offerings for eligible employees and dependents
- Well-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability insurance
- Retirement plans with employer match
- Generous paid time off
- Short-term incentive
- Long-term incentive compensation (company stock)
Company Overview
Company H1B Sponsorship