Clinical Operations Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Program Manager / Director
  3. United States
Santa Monica, USA
Posting date: 05 Oct 2020
CR.ZH.33355

Proclinical is currently recruiting for a Clinical Operations Manager with a pharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

  • Drive the development, optimization, alignment and implementation of clinical trial processes across Clinical Development.
  • Partner with equivalent functions for development, optimization and alignment of shared clinical trial processes.
  • Identify and Lead Process Improvement opportunities
  • Provide Clinical Operations SME support to the PROGRESS and POM teams
  • Establish and maintain the training curricula for Clinical Operations (inclusive of Clinical Operations, Data Management and Clinical Logistics) and support other Clinical Development functions, as needed
  • Develop Onboarding plans for Clinical Operations
  • Support transition planning within Clinical Operations as needed
  • Proactively monitor compliance with Clinical Operations procedural documents and training requirements.
  • Develop and report process and training compliance metrics
  • Support and participate in internal audits and regulatory authority inspections as needed
  • Support audit/inspection response development and CAPA implementation
  • Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary.
  • Lead and support efforts to increase compliance awareness and a culture of compliance.
  • Manage and grow the Process Improvement & Knowledge Management team as needed

Skills and Requirements:

  • In depth knowledge of international GCP regulatory requirements
  • Deep understanding of end-to-end clinical trial processes
  • Independently lead and manage cross-functional initiatives
  • Excellent communication skills, provide clear and concise instructions
  • Negotiate sensitive issues in an objective manner
  • Critical and creative thinking to be able to resolve complex problems
  • Ability to prioritize and adjust workload to meet evolving department and regulatory needs
  • Lead by example to champion quality and compliance

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

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

Proclinical Staffing is an equal opportunity employer.

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