Associate Clinical Trial Manager

Job Locations US-WA-Seattle
Job ID
2018-1118
Category
Clinical & Medical Affairs

Overview

The Associate Clinical Trial Manager (Associate CTM) is responsible for assisting the overseeing operational aspects of clinical research studies, including vendor oversight, monitoring at select sites, and other logistical operations as required. The Associate CTM will work closely with the Director of Clinical Operations and other cross-functional representatives within Dendreon, and designated CROs and vendors to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. This individual will report into the Director of Clinical Operations.

Responsibilities

  • Assists with assigned aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines and study specific manuals and procedures
  • Assist in writing or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Assist with identification and hiring of appropriate CROs and third party study vendors
  • Assist with overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits and site performance
  • Assist with CRA and third party vendor training on protocols and practices
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Perform clinical data review of data listings and summary tables, including query generation
  • Develops departmental SOPs, project-specific processes, and protocol-specific reference materials.
  • Assist in negotiating and managing the budgets and payments for investigative sites, if applicable
  • Represents department in cross functional teams, projects and related problem resolution.
  • Performs other responsibilities as assigned.

Qualifications

  • Bachelor’s degree or equivalent
  • 5-6 years clinical operations experience in the pharmaceutical industry with knowledge of GCP/ICH guidelines and the clinical development process
  • Cross-functional team leadership experience
  • Experience managing vendors, including performance assessments and finances (invoice review, change order management, budget reforecasting, etc.)
  • Experience working with an electronic data capture system and CTMS system required
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Ability to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environment.
  • Able to solve problems under pressure
  • Must be willing to travel domestically and internationally, as needed

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