We are seeking a Senior Clinical Operations Specialist with a keen attention to detail who will be responsible for assisting with oversight in clinical operations/clinical study management for several development programs. Under the guidance of Clinical Operations Management, the individual will coordinate, track, and manage daily oversight activities for multiple clinical studies to support both the internal project team and the CROs.
Performs daily oversight of full service CROs, clinical sites, and third-party vendors to ensure successful study implementation and execution.
Participate in study team meetings and review meeting minutes for accuracy and completeness.
Triage, resolve, or escalate study issues to Clinical Operations Management as needed.
Attend and participate in Investigator Meetings and study-specific training for assigned studies.
Assist in the creation and maintenance of clinical study protocols, informed consent forms, and study-specific binders/manuals/plans/tools to ensure quality and deliverables are met across assigned studies.
Monitor subject recruitment and treatment status remotely through IRT/IXRS, EDC and/or ePRO systems to maintain up to date tracking and oversight of sites and patients.
Track and manage study-related materials including IP and laboratory samples.
Collaborate with other functional groups including Data Management, Pharmacovigilance, and others to ensure precise review of the clinical study data.
Oversee CRO monitoring activities to ensure compliance with study plans, SOPs, and ICH/GCP.
Support the development of presentation slides, white papers, and dashboards reviewed by senior leadership and governance committees.
Collaborates with other functional groups in the review of the Trial Master File (TMF) to ensure quality of the documentation and compliance with study plans, SOPs, and ICH/GCP.
In conjunction with Clinical Operations Management and CRO, manages and communicates study status, timelines/critical deliverables, enrollment, quality metrics, regulatory documentation, and site start?up status for assigned clinical studies.
Review site budgets, manage clinical study budgets, and collaborate with finance to provide input into financial reporting and projections.
Responsible for submission, tracking, and coordinating CRO/vendor Confidential Disclosure Agreements (CDAs), contracts, and change orders.
In partnership with a Clinical Operations Associate, may be responsible for preparation, scheduling and distribution of meeting agendas and minutes (internal and external).
Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.
Assist with special projects for operations/departmental initiatives such as SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.
Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
Minimum four (4) years of clinical operations experience in a pharmaceutical or CRO setting.
The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
Phase 2 or 3 trial experience including site management (onsite or remote source data verification/monitoring), or closely relevant experience.
Ability to evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of the study protocol(s).
Demonstrates working knowledge of Microsoft Office applications, IRT/IXRS, and Electronic Data Capture platforms.
Demonstrates working knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently with limited oversight and be able to effectively manage multiple priorities in an environment under time and resource pressures.
Ability to travel 10 -20% domestic and internationally.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
About Travere Therapeutics
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.