Manager, Clinical Operations

Department:

Location:

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 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).

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 3specific 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 startup 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.

Education/Experience Requirements:

• Bachelors 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.

Additional Skills/Experience:

• The ideal candidate will embody Traveres 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 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.

• Phase 1 -3 trial management experience is preferred.

• Demonstrates excellent understanding of cross functional activities and input into clinical studies.

• Ability to travel (10 -20%) domestic and internationally.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse equitable people-centric and pay-for-performance organization.

Benefits: Our benefits include premium health financial work-life and well-being offerings for eligible employees and dependents wellness and employee support programs life insurance disability retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock) designed to recognize retain and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidates experience education skills and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process please contact us by sending an email to . Please note that this email address is to be used exclusively to request an accommodation with the online application interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.