Clinical Trial Manager

7 days ago

South San Francisco, California, United States Zai Lab (US) LLC Full time
Job Description

Zai Lab (US) LLC is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for leading and coordinating the operational delivery of clinical trials from study start-up to close out. This role will collaborate with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing.

Key Responsibilities
  • Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
  • Accountable for the overall operational delivery of assigned clinical trials or regions, ensuring that study-level deliverables are met according to timeline, budget, and quality requirements.
  • Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents.
  • Draft and implement study plans, including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
  • Ensure TMF creation and QC completion.
  • Support EDC, IxRS, and CTMS systems and data maintenance.
  • Track budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
  • Provide input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.
  • Participate in the selection of vendors on a global scale.
  • Oversee delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
  • Lead the Investigator Meeting preparation and execution with the support from cross-functional team members.
  • Stays current on relevant therapeutic area knowledge and clinical research best practices.
  • Ensures study adherence to ICH/GCP and company SOPs.
Requirements
  • Undergraduate degree in a scientific or health-related discipline with 5 years relevant experience of which 3 years are clinical experience in the pharmaceutical industry.
  • One year of study management experience.
  • Demonstrated ability in clinical study management processes and clinical/drug development.
  • Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders.
  • Experience with effective vendor management.
  • Strong customer focus with investigators, functional peers, vendors, etc.
  • Excellent planning and organizational skills.
  • Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
  • Ability to build trusting and collaborative relationships globally.
  • Willingness to travel domestically and internationally and work across cultures.

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