Clinical Data Manager

About the Role

Our client is looking for a meticulous and detail-oriented Clinical Data Manager to join their dedicated team in Milton Keynes . This critical role ensures the accuracy, completeness, and consistency of clinical trial data, which is essential for regulatory submissions and the successful development of new pharmaceutical products. You will work closely with clinical operations, biostatistics, and programming teams to uphold the highest standards of data quality and integrity. This is an excellent opportunity to contribute significantly to the pharmaceutical research process within a respected organization in Buckinghamshire .

Key Responsibilities

• Develop and maintain Case Report Forms (CRFs) and edit check specifications for clinical studies.
• Oversee the database build, UAT, and validation process for clinical databases.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Ensure compliance with regulatory guidelines (e.g., FDA, EMA) and internal SOPs for clinical data management.
• Participate in study team meetings, providing expertise on data management aspects.
• Perform data validation and database lock activities according to study timelines and requirements.

Requirements

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 3 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle Clinical, Clintrial).
• Strong understanding of clinical trial processes, GCP, and regulatory data standards (CDISC).
• Excellent attention to detail and analytical skills for data review and problem-solving.
• Ability to work effectively both independently and as part of a collaborative team.

Benefits

• Competitive annual salary commensurate with experience.
• Comprehensive private medical insurance and pension scheme.
• Generous holiday entitlement and bank holidays.
• Opportunities for training and professional certification in data management.
• A structured work environment within a modern facility in Milton Keynes .
• Contribution to vital pharmaceutical research impacting global health.