Senior Clinical Trial Manager

Redwood City, CA 94063

Posted: 06/23/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17594

Job Description


 

What You’ ll Do
  • Serves as primary study team contact to manage the start-up, conduct and close-out of clinical studies.
  • Leads the cross-functional study execution team to ensure that project milestones are met and adhere to approved budgets and are in compliance with ICH/GCP and local Regulatory Authorities’
  • Helps with the development, planning and forecasting of budget requirements for the clinical programs and clinical study sites.
  • Manages CRO and vendor evaluation, selection, training and oversight
  • Facilitates site feasibility/selection processes.
  • Conducts Sponsor quality monitoring/oversight visits to sites as needed.
  • Provides strategic and operational input into the development of study documents including the study protocol, ICF, CRFs, pharmacy manual, laboratory manual etc.
  • Oversight of preparation and submission of safety reports (pharmacovigilance)
  • Supply chain management. Forecast and manage investigational drug labeling, packaging and distribution.
  • Ensuring clinical record keeping in preparation for audits and inspections.
  • Identification and engage of thought leaders, investigators, cooperative groups and other experts regarding latest clinical thinking, study design, study conduct and interpretation of study results.
  • In conjunction with data management, assist with EDC development, preparation and/or review of data listings, issue and query resolution.
  • Collaborate on the development and set-up of study systems (e.g. IVRS/IWRS, site payments and CTMS). 
  • Develops and reports key executional metrics for the oversight of the clinical trials.
  • Assists with creating, reviewing and implementing SOPs and processes in clinical development.
  • Approximately 10-15% travel may be required.

 

About You
  • Bachelor’ s degree preferred. Certification in health-related field or Associates degree required. Preference in a health care or scientific discipline.
  • At least 5 years CTM experience  in a pharmaceutical, biotechnology setting. 
  • Excellent verbal, written communication skills and interpersonal and presentation skills are required. 
  • Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with email and calendar programs. Experience with IVRS and EDC systems a plus. 
  • Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. 
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures. 
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools. 
  • Strong attention to detail and excellent organization skills. 
  • Strong interpersonal skills and communication skills (both written and oral)  able to work effectively in a team/matrix environment. 
  • Experience in gene therapy and/or rare disease indications preferred

 

 

Meet Your Recruiter

Felicia Id-Deen

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