Immune Design

Clinical Trial Manager

US-CA-South San Francisco
2 months ago(10/27/2017 10:25 AM)
ID
2017-1039
# of Openings
1

Overview

The Clinical Trial Manager performs project management activities and provides daily management of multiple study activities. The CTM is responsible for setting up and managing functional aspects of studies including Clinical Research Organization (CRO) selection/oversight, investigational product, lab sample, and financial accountability. The CTM may also be responsible for monitoring clinical sites or to assist in oversight of monitoring to verify that the rights and well‑being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs.

Responsibilities

  • Plans and assists study start-up activities such as, the CRO pre-site selection, CRO Contract and Budget Process, creation of Monitoring Plan, Laboratory Manual, Pharmacy Manual, Site Initiation Presentations, CRF Completion Guidelines, and various forms, study tracking and management documents
  • Oversight of CRO, including project tracking of subject and site information, and generation of metrics and updates for senior management
  • Management and oversight of clinical study files/documents within electronic and/or paper Trial Master File
  • As required, participates in the development, review and implementation of departmental SOPs and processes
  • Reviews and approves (as required) site study documents (informed consent template and study tools/worksheets), investigator contracts/budgets, and site payments
  • Assists with protocol, IB, and CRF development
  • Performs or oversees CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
  • Reviews and manages monitoring reports and follow-up within project-specific timelines
  • Develops and revises RFPs, SOWs, study and site budgets/contracts including performance metrics
  • May manage direct reports (Clinical Trial Specialist (CTS) Clinical Project Coordinator (CPC)
  • Recommends and implements innovative process ideas to impact clinical trials management and success
  • Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
  • As required, Participates in the development, review and implementation of departmental SOPs and processes

SUPERVISORY RESPONSIBILITIES:

  • Manages activities of two or more sections or departments.
  • Exercises supervision in terms of costs, methods, and staffing.
  • In some instances, this manager may be responsible for a functional area and not have subordinate employees.

Qualifications

 

  • Bachelor’s level degree in life sciences, pharmacy or nursing; RN preferred
  • Prior related clinical trial management experience
  • Oncology experience preferred with Global experience preferred
  • Experience managing outside vendors, e.g., CROs and labs
  • Able to provide clinical operations expertise to clinical development in a specified product area or project
  • Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
  • Knowledge of clinical research operations, including interpretation and implementation of cGCP, FDA regulations, and ICH guidelines is required. Global (Ex-US) regulatory experience a plus.
  • Able to deal with time demands, incomplete information or unexpected events
  • Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines.
  • Advanced capabilities with Microsoft PowerPoint, Word, Excel, and Project desired.
  • Basic math and standard business level English grammar and usage.
  • Able to travel approximately 20% overnight (50% or greater during peak times).

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