GCP QA Consultant Job at Proclinical (Berlin)

GCP QA Consultant

Proclinical

Location:
Germany , Berlin

Category:
Research and Development

Contract Type:
Not provided

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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