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GCP QA Consultant

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Proclinical

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Location:
Germany , Berlin

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Proclinical is seeking a GCP QA Consultant to support quality assurance activities for oncology-focused clinical trials. This role involves overseeing quality processes for phase 2-3 studies, ensuring compliance with ICH-GCP and regulatory requirements, and managing risk-based quality plans. You will collaborate with internal teams and external partners to maintain high standards of clinical trial execution and inspection readiness.

Job Responsibility:

  • Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans
  • Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
  • Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking
  • Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements
  • Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings
  • Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements
  • Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events
  • Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans
  • Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes
  • Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready
  • Identify and address deviations, enforce corrective actions, and recommend process improvements
  • Issue performance summary reports, define and measure KPIs, and escalate serious breaches when necessary
  • Support change control requests related to clinical study materials or tools, providing quality input
  • Develop and implement inspection readiness programs, supporting sites and staff during inspections
  • Mentor and lead other Quality Assurance GCP Specialists
  • Work with Regulatory Affairs on updated submissions or reporting requirements

Requirements:

  • Strong knowledge of ICH-GCP guidelines and regulatory requirements
  • Experience in quality assurance for clinical trials, particularly in phase 2-3 studies
  • Proficiency in risk management and quality oversight processes
  • Ability to manage and maintain TMF documentation and ensure inspection readiness
  • Skilled in identifying deviations, implementing corrective actions, and driving process improvements
  • Excellent communication and collaboration skills to work with cross-functional teams and external partners
  • Familiarity with Clinical Trial Agreements, site feasibility, and activation processes
  • Leadership and mentoring abilities to guide junior team members

Additional Information:

Job Posted:
January 05, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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