Clinical Research Operations Senior Specialist
2 months ago
We are seeking a highly skilled Quality Manager to uphold the quality of our client's clinical trials. This role involves working closely with clinical operations and regulatory teams to ensure compliance with Good Clinical Practice (GCP) and relevant industry standards.
Key Responsibilities:
- Implement and manage the quality management system (QMS) within clinical operations
- Ensure adherence to GCP, Standard Operating Procedures (SOPs), and regulatory requirements
- Oversee data quality from clinical trials, ensuring accuracy and consistency
- Conduct quality control audits of trial sites, identifying gaps and recommending corrective actions
Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field
- Advanced degree (Master's or PhD) or equivalent experience in clinical research or pharmaceutical quality management
- Minimum of 5 years of experience in clinical research, focusing on quality assurance or quality management
- Experience as a Clinical Research Associate (CRA), ideally within a pharmaceutical company or Contract Research Organization (CRO)
Collaboration and Communication:
- Strong communication, analytical, and problem-solving skills
- Ability to work collaboratively in cross-functional teams
- Provide guidance on quality and compliance issues to research teams and senior management
Working with Kontak Recruitment:
- Kontak Recruitment specializes in niche fields and welcomes all backgrounds
- Equal opportunity employer with a fair assessment process
- Data is processed according to the Privacy Policy, and applicants agree to data handling
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