Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials and gain deeper insights through technology-driven solutions and expert services. The company specializes in EDC development, systems integration, AI deployment, clinical data science, project management, and integrated dashboards that streamline operations and enhance data quality. By creating unified data ecosystems and intuitive visualization tools, ClinFocus supports faster, more informed decision-making throughout the trial lifecycle. As an ISO-certified organization and accredited Medidata Rave partner, ClinFocus is committed to excellence, reliability, and strong work ethics. Team members collaborate with global clients on innovative clinical research initiatives that advance drug development.
Role Description The Clinical Data Manager is a full-time, remote role responsible for overseeing the planning, execution, and maintenance of clinical data activities across assigned studies. Day-to-day tasks include designing and reviewing case report forms, configuring and testing EDC systems, and developing data management plans and edit checks. The role involves ongoing data review, query management, data validation, and reconciliation of external data sources to ensure accuracy, completeness, and consistency. The Clinical Data Manager collaborates closely with clinical operations, biostatistics, programming, and sponsor teams to align data standards, timelines, and quality expectations. Additional responsibilities include supporting database lock activities, contributing to process improvements, and ensuring compliance with regulatory guidelines, SOPs, and industry best practices.
Qualifications
- Candidates should possess strong skills in Data Management and Clinical Data Management for the planning, oversight, and execution of clinical study data activities.
- Candidates should possess skills in Clinical Data and Data Validation to ensure data accuracy, consistency, and integrity across all study datasets.
- Candidates should possess hands-on experience with Electronic Data Capture (EDC) systems, including EDC configuration, testing, and maintenance.
- Relevant experience in clinical research, CRO or pharmaceutical environments, with familiarity with ICH-GCP, CDISC standards, and regulatory requirements.
- Proficiency with clinical data tools and MS Office (especially Excel), and comfort working with large datasets and data review listings.
- Strong analytical, problem-solving, and documentation skills, with attention to detail and commitment to data quality.
- Effective written and verbal communication skills, and the ability to collaborate in a remote, cross-functional, and international team setting.
- Bachelor’s degree or higher in life sciences, pharmacy, statistics, computer science, or a related field; advanced degrees or relevant certifications in clinical data management are a plus.
