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Clinical Trial Manager
Ref No.: 15-11423
Location: Redwood City, California
Position Type:Contract
Experience Level: 5 Years
Contact Tara Brabham, Sr. Recruiter to apply directly

Clinical Trial Manager

Permanent position
San Francisco Bay area

  • Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.
  • Leads study management team, including oversight of CRO and Vendors.
  • Coordinates the training of staff involved in clinical trial management.
  • Provides training to clinical operations staff and performs performance appraisals of direct reports.

  • Responsible for the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
  • Responsible for the selection of investigators and study sites
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor
  • Coordinates the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
  • Ensures that CRF data queries are resolved
  • Coordinates and manages Investigational Product including overall accountability and reconciliation
  • Responsible for the preparation of study budgets and timelines
  • 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 all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG)
  • Responsible for selection of CRO study staff and coordinating training including documentation
  • Hires, trains and oversees study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
  • Leads with minimal supervision in the planning of investigator meetings and making presentations, as required
  • Leads the 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 Site Initiation Visits (SIVs) as required
  • Co-Monitors of 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
  • Supervises Clinical Trial Assistants and Clinical Research Associates, and performs performance appraisals
  • Performs other duties as assigned

  • BA/BS/MS in a scientific discipline
  • 5+ years of relevant clinical operations experience in a CRO or pharmaceutical
  • Must have some direct Pharma or Biotech (not all CRO experience)
  • At least 3 years of CRA experience and 2 years of CTM experience
  • Experience in oncology is required - MUST HAVE ONCOLOGY EXPERIENCE
  • Experience in Solid Tumor preferred
  • Must have demonstrated expertise in relevant clinical operations activities
  • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks to subordinates
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint