Job Details

  • Title: Clinical Trial Leader
  • Code: RCI-FSP-1776
  • Location: Irvine California (CA) 92618
  • Posted Date: 04/22/2019
  • Duration: open Months
  • Status: Open
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  Job Description

Clinical Trial Leader

Job Description:

  • Clinical study execution in support of the Client’s team and their overall Clinical Center of Excellence with a focus primarily on clinical cardiovascular studies.
  • Fostering strong, productive relationships with colleagues within the organization
  • Serving as a member or leader of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
  • Overall execution of small-medium-large regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure
  • Providing support to department wide training
  • Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects
  • Leading several small/medium/large clinical studies (regulated and non-regulated) that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
  • Assisting with or leading the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
  • Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
  • Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
  • Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
  • Evaluating support requests for publications and to provide consolidated comments and support to the requests.
  • Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
  • Tracking assigned projects budgets to ensure adherence to business plans.
  • Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
  • Independently solves problems arising during clinical study execution and will seek guidance for more complex problems as needed
  • Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
  • Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
  • Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
  • May serve as the primary contact for clinical trial sites
 

Qualifications

  • A minimum of a Bachelor’s Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred
  • 5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager
  • 1+ years of Clinical Project Management experience
  • Cardiovascular clinical trial experience strongly preferred
  • Personnel management experience strongly preferred
  • Medical device experience is preferred
  • The ability to influence others along with strong written and oral communication skills is required
  • Knowledge of Good Clinical Practices is required
  • Understanding and application of regulations and standards applied in clinical areas is required
  • Advanced project management skills with the ability to handle multiple projects required
  • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
  • Strong written and oral communication skills