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Clinical Data Manager
- newcastle upon tyne, tyne and wear, NE2 1RQ, United Kingdom
- Permanent·Hybrid
- Full time
- £55,000 - £55,000 Per Annum
Job Description
About the Role
Our client seeks a meticulous Clinical Data Manager to ensure the accuracy, integrity, and security of clinical trial data. This hybrid role involves a balance of working from home and collaborating with the team in our Newcastle upon Tyne office. You will play a critical part in managing data from clinical studies, ensuring compliance with regulatory standards and contributing to the successful development of new pharmaceuticals. This position is essential for maintaining the quality of data that underpins our drug approval processes, working within a dedicated team focused on rigorous data governance and operational excellence.
Key Responsibilities
- Oversee the design, development, and maintenance of clinical databases and data management plans.
- Ensure data accuracy, completeness, and consistency throughout the clinical trial lifecycle.
- Develop and execute data validation checks and identify, resolve, and document data discrepancies.
- Collaborate with clinical research associates, investigators, and statisticians on data-related issues.
- Generate and review database lock reports and facilitate the final database closure.
- Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.
Requirements
- Bachelor's degree in a life science, computer science, or related field.
- Minimum of 3 years of experience in clinical data management within the pharmaceutical or biotech industry.
- Proficiency with Electronic Data Capture (EDC) systems and clinical data management software.
- Strong understanding of clinical trial processes and regulatory guidelines (e.g., ICH GCP).
- Excellent attention to detail and organizational skills.
- Effective communication and interpersonal skills for team collaboration.
Benefits
- Competitive salary and annual bonus.
- Hybrid work model offering flexibility.
- Comprehensive medical, dental, and vision benefits.
- Pension scheme with employer contributions.
- Opportunities for professional development and training.