Proclinical is seeking a dedicated Clinical Quality Assurance Manager.
This role is crucial in ensuring that clinical trials and studies are conducted to the highest quality standards, in compliance with international standards, legislation, protocols, and company processes.
The successful candidate will be instrumental in the development and improvement of the Company's Quality Management System and will play a key role in maintaining compliance with GCP, protocols, and legislation.This position holds a fully remote working model from within Italy or Spain.Responsibilities:Review and contribute to the development and improvement of the Company's Quality Management System and controlled documents related to clinical operations.Interpret and consult on regulations, guidelines, and standards.Ensure clinical trials/studies compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, Policies and Guidelines.Deliver quality-related training sessions to all staff.Conduct clinical suppliers' assessment and performance monitoring.Conduct clinical trial-specific documents audits, as well as on-site and data management audits.Perform regular checks to ensure clinical trial/study specific plans are executed.Produce clinical trial/study-specific quality metrics for executive and operational insights.Ensure deviations, non-conformances and potential non-conformances are properly documented, addressed, and monitored for effectiveness.Develop periodic reports describing compliance/non-compliance trends, identify areas of potential risk.Contribute to audits the Company receives from Clients and Competent Authorities.Key Skills and Requirements:Bachelor's degree in natural or health sciences or related field.Master's degree in natural or health sciences or related field.Certification of knowledge of clinical trials standards (e.g., ICH GCP etc.
)Certification of knowledge of quality assurance standards (e.g., ISO 9001, etc.)
is a strong advantage.Proven experience as a Clinical Quality Assurance Manager / Senior GCP auditor or experience in quality for clinical trials in CROs and/or pharmaceutical companies.Previous experience with GCP system audits, Site and documentation audits and/or regulatory inspections.Excellent command of spoken and written English.
Knowledge of other languages is an asset.Great attention to detail and a result-driven approach.Outstanding communication and interpersonal skills.Good knowledge of MS Office and databases savvy.Advanced numerical skills and understanding of data analysis / statistical methods.Ability to deal adequately with stressful situations, flexible timelines and work pressure.Team working skills.Willingness to travel.
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