Clinical Project Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United States
Irvine, California
Posting date: 12 Apr 2019
CR.MS.22727_1555077808

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical Project Management position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its California-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • Clinical study execution in support of the overall Clinical Center of Excellence with a focus primarily on clinical neurovascular 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.

Skills and Requirements:

  • 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.
  • Neurovascular clinical trial experience strongly preferred.
  • Personnel management experience strongly preferred.
  • Medical device experience is preferred.
  • 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).
  • Excellent project management, consensus building, and leadership skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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