Senior Manager, Clinical Operations

Department:

106600 Clinical Operations

Location:

San Diego

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 Senior Manager, Clinical Operations is responsible for supervision and execution of the clinical operations 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). 

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.

• Ability to evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply understanding of study protocol(s).

• Manages 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.

• Guides 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.).

• Ability to 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.

• Ability to provide basic strategic input into areas of study management.

 

Education/Experience Requirements: 

• Bachelor’s degree or equivalent combination of education and applicable job experience may be considered.

• At least 7 years of clinical trial experience with minimum 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.

• Phase 1 -3 study experience or relevant experience including international studies is preferred.

Additional Skills/Experience: 

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.

• Proactive, self-starter who possesses the desire to take on additional tasks (in and out Clinical Operations).

• Ability to establish goals for assigned studies and can 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.

• Should have strong skills in MS Office and timeline software such as MS Project or Smartsheet.

• Experience with clinical systems such as I