Clinical Trial Manager

Redwood City, CA 94065

Posted: 02/25/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 15126

Clinical Trial Manager 

Contract-to-hire

Redwood City, CA

 

Job Duties:
  • Responsible for the preparation and finalization of project and study-related documents including: feasibility questionnaires, informed consent forms, study plans, EDC/CCGs, lab manuals
  • Assist in the selection of investigators and study sites
  • Ensures clinical studies are conducted on-time, within budget and with quality
  • Provides tactical and strategic oversight of clinical studies
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Head of Clinical Operations
  • Coordinates the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC, IRT, ePRO specification process, system design meetings, and UAT
  • Ensures that CRF data queries are resolved
  • Coordinates and manages Investigational Product including overall accountability and reconciliation
  • Manages project timelines and vendor performance to meet departmental and corporate goals
  • Manages study budget and payment process for all clinical trial vendors including investigative sites
  • Monitors and tracks clinical trial progress and provide status update reports
  • Manages clinical trial vendors (e.g., IRT, central lab, central imaging, ePRO, central pathology, biomarker labs)
  • Responsible for selection of CRO study staff and coordinating training including documentation
  • Review of trip reports and provide guidance on site issues
  • Planning of investigator meetings and making presentations, as required
  • Review of clinical data at the CRF, data listing, and report table levels
  • Represents Clinical Operations at the Project Team level for individual studies, as appropriate
  • Partners with other research and development groups to achieve deliverables
  • Participates in Qualification Visits, Site Initiation Visits, Close out Visits as required
  • Monitoring oversight of CRAs and regional sites for adherence to protocol and GCP as required
  • Identifies and escalates site, vendor and study related issues to supervisor, as appropriate
  • Participates in clinical and department settings, including attending additional meetings as required, and interacts in a positive and professional manner
  • Performs other duties as assigned with minimal supervision

 
Requirements:
 
  • Must have demonstrated expertise in relevant clinical operations activities
  • Approximately 25%-35% travel 
  • Self-motivated, adaptable to a dynamic, fast-paced work environment
  • Ability to exercise independent judgment
  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations

 
Education/ Training:
  • BA/BS in a scientific discipline
  • Minimum 2  years of relevant CTM experience in a CRO or pharmaceutical, including 3  years as an in-house Clinical Research Associate (CRA).
  • Experience in oncology is a must; hematology preferred
  • Experience in global trials preferred

Jesse Ashworth

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