This role involves overseeing the start-up and execution of clinical trials, ensuring data quality and integrity, and providing leadership in data management for clinical development programs. The individual will perform complex tasks to ensure complete, accurate, high-quality, and regulatory-compliant data for publications and regulatory submissions.
Responsibilities
Lead and be accountable for data management deliverables within a given development program
Develop, maintain, and execute data management timelines for a given development program
Provide Data Management Leadership in program-related audits and regulatory inspections
Lead and participate as data management subject matter expert at Study Management Team meetings
Identify gaps in existing data management processes within a program and champion process change efficiencies
Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM to ensure successful clinical trial implementation and execution to completion
Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs
Review data for protocol deviation identification, as well as coding, and user acceptance testing of database
Review documents produced by vendors and other departments
Work cross-functionally with other departments within the company assessing and understanding their needs and attend clinical trial project team meetings as Lead CDM
Strategize and plan for database locks and multiple deliverables across numerous programs
Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective
Provide guidance to clinical data management personnel on assigned projects
Set-up, maintain, and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.)
Independently monitor own activities and project status for successful project deliverables according to timelines
Ensure project is in reasonable state of inspection readiness and compliance
Design clinical trials utilizing CDASH and SDTM standard terminology
Manage system integrations across data platforms
Perform additional duties as assigned
Requirements
Bachelor’s degree in life science, pharmacy, or related field
Equivalent combination of education and applicable job experience may be considered
8+ years of direct Data Management experience
Prior clinical trial vendor management and integration experience
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Experience in solving complex and increasingly difficult problems, taking appropriate corrective action, and identifying and implementing improvements
Knowledge of Clinical Data Management processes and capable of providing guidance to peers
Demonstrate initiative, sound judgment, and flexibility
Effective time management and organizational skills
Capable of working on multiple projects simultaneously under tight timelines or heavy stress
Project management skills (i.e., plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets)
Ability to interact professionally with personnel at all levels within and external to the company
Dependable and a team player
Clear understanding of drug development process
Understanding of ICH Guidelines and GCP Requirements
Experience/Understanding of dictionary coding (i.e., MedDRA and WHODrug) and vendor reconciliation
Ability to develop and maintain timelines
Self-motivated and can independently manage responsibilities
Nice to have:
Experience in managing outsourced studies and working for a CRO
Proficiency in Medidata RAVE EDC System
Experience in leading data integrations using EDC, IRT, ePRO, and external laboratory processing
Experience in the use of Artificial Intelligence (AI) models to create efficient data collection methodologies or enhance data quality
Benefits
Comprehensive total rewards offerings
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
Generous paid time off
Short-term incentive compensation
Long-term incentive compensation (company stock)
Important Details
Travel: approximately 10%
Work format: No role is expected to be 100% remote; all positions have an essential job function to be able to perform face-to-face work with colleagues and/or onsite in San Diego.
Application deadline: Applications accepted on an ongoing basis until a candidate is selected.
About the Company
Travere Therapeutics is a global team focused on identifying, developing, and delivering life-changing therapies to people living with rare diseases. The company is dedicated to elevating science and service for rare patients, guided by values centered on patients, courage, community, and collaboration.
Our mission is to identify, develop and deliver life-changing therapies to people living with rare disease..
