Clinical Data Manager

📋 Description

• • As a Clinical Data Manager at Clario, you will be at the forefront of ensuring the integrity and accuracy of critical clinical trial data, specifically focusing on the imaging aspects of studies across diverse therapeutic areas.
• • Your primary responsibility will be to meticulously review and evaluate the clinical data generated throughout the trial lifecycle, acting as a guardian of data quality and completeness.
• • You will play a pivotal role in managing study data, implementing rigorous edit checks, and proactively collaborating with a dynamic, cross-functional project team to identify and resolve any data discrepancies.
• • This role is essential for maintaining the high standards of clinical trial databases, ensuring that all data collected is accurate, reliable, and fully compliant with stringent regulatory requirements and specific study protocols.
• • Through your keen attention to detail, sharp analytical thinking, and exceptional collaboration skills, you will directly contribute to the successful execution of clinical trials, ultimately supporting the development of life-changing therapies.
• • You will be responsible for performing all data management deliverables for your assigned studies, from initial setup to final database lock.
• • This includes actively participating in client meetings, providing expert insights on data management strategies and progress as requested.
• • A core part of your role will involve understanding and translating study requirements into actionable data collection and management plans.
• • You will work closely with project managers, clinical research associates, biostatisticians, and other stakeholders to develop study-specific edit check criteria that effectively identify potential data issues.
• • The execution and review of these edit checks, followed by the systematic resolution of any identified discrepant data, will be a daily focus.
• • Maintaining an organized, complete, and up-to-date study documentation is paramount, ensuring a clear audit trail and adherence to Good Clinical Practice (GCP) guidelines.
• • You will be involved in crucial study setup activities, including defining the database structure, developing comprehensive specifications, and obtaining necessary approvals.
• • Coordinating and meticulously documenting the receipt and processing of electronic or ancillary data from external sources, such as central laboratories, Contract Research Organizations (CROs), or sponsors, will be a key function.
• • Proactive communication is vital; you will be expected to keep supervisors informed of project status, potential risks, and any emerging issues, enabling timely intervention and problem-solving.
• • Ensuring the accuracy and consistency of clinical databases involves a continuous cycle of reviewing clinical data, identifying errors or inconsistencies, and collaborating with project teams to implement corrective actions.
• • You will be responsible for tracking outstanding issues, diligently following up until their complete resolution, and ensuring that all clinical data management activities strictly adhere to regulatory guidelines (e.g., FDA, EMA) and study protocols.
• • Beyond direct data management, you will contribute to the overall quality system by adhering to Clinical Data Management procedures, policies, and work instructions.
• • Reading, understanding, and following applicable Standard Operating Procedures (SOPs) is a non-negotiable aspect of this role.
• • You will have the opportunity to assist in establishing and maintaining departmental standards, contributing to the continuous improvement of data management practices.
• • Participation in the review and update of company SOPs related to Data Management services will be encouraged, allowing you to shape best practices.
• • Working collaboratively with internal teams to resolve complex issues and support overarching operational goals will be a regular part of your responsibilities.
• • You will contribute to a positive team environment by supporting colleagues and actively sharing your knowledge and expertise.
• • Engaging in company-sponsored training and maintaining an awareness of evolving industry best practices will be essential for professional growth.
• • Finally, you will be expected to perform additional tasks and responsibilities as assigned, demonstrating flexibility and a commitment to the company's success.