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杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a GCP QA Consultant to support quality assurance activities for oncology-focused phase 2-3 clinical trials. This role emphasizes risk management, compliance with ICH-GCP and regulatory requirements, and inspection readiness. You will collaborate with cross-functional teams to ensure study quality, monitor performance, and maintain transparent communication between clinical operations and quality assurance.
Responsibilities:
- 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.
- Participate in process audits and act as the Clinical Quality Assurance Representative at weekly monitor-site meetings.
- Ensure effective site monitoring and recommend improvements for site and monitor performance.
- Maintain adherence to study plans, SOPs, and ensure transparent communication regarding quality events.
- Ensure clinical trial trackers are updated and maintained by the clinical operations team.
- Own and maintain the Clinical Trial Oversight Plan and Clinical Quality Plan.
- Ensure Clinical Trial Agreements are in place and adhered to, and that site feasibility, qualification, initiation, and activation are documented in the TMF.
- Collaborate with TMF specialists to ensure the TMF remains inspection-ready and accurately reflects study documents.
- Raise deviations, enforce corrective actions, and recommend improvements as needed.
- Issue summary reports based on site and monitor performance, defining and measuring KPIs.
- Escalate suspected serious breaches to senior leadership.
- Review and assess potential impacts of Change Control requests related to clinical study materials or tools.
- Develop and implement inspection readiness programs, supporting sites and internal staff during regulatory inspections.
- Mentor and lead other Quality Assurance GCP Specialists.
- Work with Regulatory Affairs on updated submissions or reporting to CTIS-ClinicalTrials.
Key Skills and Requirements:
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in quality assurance for phase 2-3 clinical trials, particularly in oncology.
- Proficiency in risk management and endpoint de-risking strategies.
- Ability to conduct risk-based document reviews and participate in process audits.
- Skilled in developing and maintaining clinical trial plans and trackers.
- Familiarity with TMF management and inspection readiness activities.
- Effective communication and collaboration skills across cross-functional teams.
- Proven ability to mentor and lead other professionals in quality assurance.
- Experience with regulatory submissions and reporting processes.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.
Apply Now:
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杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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