Clinical Data Manager - Pharmaceutical Trials

About the Role

Our client is seeking an experienced Clinical Data Manager to join their clinical operations team, working a hybrid model with a base in Oxford . This role is crucial for ensuring the accuracy, completeness, and integrity of clinical trial data, which is vital for regulatory submissions and scientific analysis. You will be responsible for managing the clinical data lifecycle from database setup to database lock. This position offers an excellent opportunity to contribute to the development of life-saving therapies in a collaborative and scientifically driven environment.

Key Responsibilities

• Oversee the design, development, and validation of clinical data management systems (e.g., EDC).
• Develop and maintain Case Report Forms (CRFs) and eCRFs in collaboration with clinical study teams.
• Define data validation checks and implement data cleaning strategies to ensure data quality.
• Manage data review processes, query generation, and resolution with clinical sites.
• Perform User Acceptance Testing (UAT) for clinical databases and related tools.
• Prepare and archive study data management documentation, leading to database lock.
• Ensure compliance with ICH GCP guidelines and relevant data privacy regulations.

Requirements

• Bachelor's degree in a scientific, healthcare, or related field.
• Minimum of 3 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes, ICH GCP guidelines, and data standards (e.g., CDISC).
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and interpersonal skills, essential for a hybrid role requiring site interaction in Oxford .

Benefits

• Competitive salary and performance-related bonus.
• Hybrid working model providing flexibility.
• Comprehensive medical, dental, and vision coverage.
• Generous pension scheme and life assurance.
• Support for professional development and training in clinical data management.