Manager, Clinical Operations

Travere Therapeutics•San Diego, CA

1d•Onsite

About The Position

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Manager, Clinical Operations is responsible for overseeing clinical operations/clinical trial management for Phase 1 – 3 clinical trials. Under the guidance of Clinical Operations Management, the individual will coordinate, track, and manage daily trial activities to support both the internal project team and the Contract Research Organizations (CROs).

Requirements

Bachelor’s degree or equivalent combination of education and applicable job experience may be considered.
At least 6 years of clinical trial experience with at least 1 year managing aspects of studies internally or at another Sponsor (or CRO) or similar experience at a clinical site.
Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP.
Phase 1 -3 trial management experience is preferred.
Proactive, self-starter who possesses the desire to take on additional tasks (in and out Clinical Operations)
Ability to establish goals for multiple priorities/assigned studies and can execute within an established timeframe with limited oversight
Ability to identify issues, determine cause, and propose solutions with limited oversight
Proficient communication skills, both oral and written with ability to present study updates at various cross-functional meetings.
Proficient problem-solving skills and critical thinking skills
Strong sense of urgency, keen attention to detail, and ability to work independently
Should have strong skills in MS Office and timeline software such as MS Project or Smartsheet.
Experience with clinical systems such as IRT, eTMF, etc.
Demonstrates excellent understanding of cross functional activities and input into clinical studies.

Nice To Haves

Phase 1 -3 trial management experience 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.
Provide direct oversight and management of multiple specialty vendors (e.g., central laboratory, central ECG, electronic Patient Report Outcomes/electronic Clinical Outcome Assessments, imaging, and other Phase 3–specific vendors), ensuring alignment with study timelines, scope, and quality expectations
Triage, resolve, or escalate study issues to Clinical Operations Management with limited oversight. Serve as the primary point of contact for vendor-related issue escalation, driving resolution of operational, data quality, and timeline risks
Ability to evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply understanding of study protocol(s).
Oversee vendor timelines and deliverables across rare disease studies, ensuring integration into overall study timelines and critical path activities.
Partner cross-functionally (e.g., Data Management, Clinical Supply, Biometrics) to ensure vendor deliverables meet data integrity and regulatory expectations
Track study status, timelines, enrollment, regulatory documentation, and site start‐up status (as applicable) for assigned clinical trials.
Track and report vendor performance metrics (KPIs), including data turnaround times, query rates, and service level agreement (SLA) adherence
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).
Contribute to vendor-related sections of study documents (e.g., lab manuals, eCOA specifications, imaging charters) and ensure alignment with protocol requirements.
Manage vendor budgets, review invoices, and support contract scope discussions, including change orders and financial forecasting
Oversee vendor logistics and sample/data flow processes (e.g., central lab sample tracking, ECG data transfers, ePRO compliance).
Facilitates cross functional activities in establishing and meeting SMT goals and can communicate key issues and mitigations to relevant cross-functional stakeholders.
Lead or contribute to vendor governance meetings, including vendor kick-offs, regular review meetings, and performance reviews.
Ability to provide clinical operation input into areas of study design, execution and delivery of clinical studies.
Provide clinical operation input on vendor selection, feasibility, and operational strategy for Phase 3 rare disease trials.