Study Monitor - Clinaxel Europe
La información a continuación detalla los requisitos del puesto, la experiencia esperada del candidato y las cualificaciones correspondientes.
Clinaxel is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.
We're actively seeking a Study Monitor based in Spain to join our expanding Field Clinical Trials team.
This role provides the flexibility to work remotely, with occasional visits to Clinaxel offices based in the North of France.
Primary Job Purpose
Responsible for performing monitoring activities to ensure clinical trials are conducted in compliance with study protocols, VICH GL9 GCP guidelines, and applicable regulatory requirements. This role involves verifying data accuracy, ensuring site adherence to timelines and quality standards, and supporting the overall success of clinical trials.
Job Specific Duties and Responsibilities
Conduct routine site monitoring visits across all trial phases to ensure compliance with study protocols, GCP guidelines, and regulatory requirements.
Verify the accuracy and completeness of data collected at study sites, identifying and resolving discrepancies as needed.
Serve as a point of contact for assigned study sites/investigators, facilitating communication and addressing site-level issues.
Assist in the preparation and review of study-related documentation, including monitoring reports and site records.
Ensure site adherence to established timelines, quality standards, and budgetary constraints.
Document and elevate risks or issues that may impact study timelines or data quality to the appropriate stakeholders.
Monitor scientific and regulatory developments to ensure compliance and the updating of practices during clinical trial oversight.
Provide guidance and support to site staff on study protocols, compliance requirements, and best practices.
Qualification, Training and Experience Requirements
Bachelor's degree in a relevant Life Sciences field.
Minimum of two years' experience in GCP Study Monitoring within Animal Health or Human Pharma sectors.
Familiarity with regulatory guidelines such as VICH GL9 GCP and their application in clinical trials.
Ability to work and communicate in English.
Strong organizational skills to manage tasks efficiently and ensure adherence to timelines.
Important Note to Applicants
This is a remote position, with the potential for regular travel based on project requirements.
The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website. Personal data will be used solely for recruitment purposes and handled with strict confidentiality. xpzdshu
Please send us your resume and a cover letter detailing your interest in the position.
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