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CRO/Pharma

Quality Clinical Manager

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Job Code: 02
Posted On: czwartek, 31st sierpień 2017
Category: Pharmaceutical
Department: Quality Assurance
Location: Warsaw
Job Type:
Full Time
Education: Graduate Degree
Pay Rate: negotiable
Duration: permanent
Travel: yes

Job Description:

  • Cooperates with Clinical Operations staff and other relevant Pharmacyclics GmbH functional group staff to develop, implement and maintain the Clinical Operations Clinical Quality Management Plan.
  • Monitors and identifies Clinical Operations SOP gaps and other work process gaps, and develops strategy for addressing gaps.
  • Collaborates with other Pharmacyclics departments to ensure cross-department SOPs are in accordance with current practices and GCP requirements.
  • Leads the development of new Clinical Operations SOPs and Work Process Guidance Documents, as well as maintenance of existing SOPs and Work Process Guidance.
  • Supports Clinical Operations staff with interpretation and application of global GCP regulations..
  • Provides clinical trial GCP compliance training to Clinical Operations staff as appropriate and necessary
  • Collaborates with Pharmacyclics Clinical Quality Assurance in the strategic planning, preparation and support of Regulatory Authority GCP inspections, including sponsor, clinical site and clinical vendor inspections.
  • Performs GCP compliance assessments of clinical projects and clinical sites as required and requested

Preferred Skills:

Skills/duties

  • 5 years Clinical Operations experience, including clinical monitoring and clinical trial management experience
  • Prefer prior GCP compliance and clinical quality management experience
  • Prefer previous experience directly supporting the development of Regulatory Authority GCP inspection support plans and processes
  • Prefer previous experience directly supporting a Regulatory Authority GCP sponsor inspection in a key role
  • Prefer previous experience directly supporting a Regulatory Authority GCP clinical site inspection
  • Prefer previous experience in training
 
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