The Clinical Data Specialist is responsible for setting up, documenting, implementing, and locking clinical study databases and data to meet regulatory standards. They work closely with senior data management members to ensure compliance with industry expectations.
Duties And Responsibilities
Perform data management activities following regulations and SOPs
Contribute to developing, testing, and locking study-specific databases
Review and contribute to protocols from a data management perspective
Manage the process from DMP development to data export
Design and review eCRFs, create data dictionary, and manage medical coding
Develop and execute electronic data edit checks
Perform quality control on study data and programs
Collaborate with other team members to meet project deliverables
Perform data entry and other related tasks as needed
Qualifications
Experience in data management or related activities
BA or BS in a science or related field
Understanding of database structures and programming
Knowledge of CDISC standards and clinical trial processes
Proficiency in MS Windows, Word, Excel, PowerPoint, and email applications
Strong analytical, problem-solving, and communication skills
Self-motivated with the ability to learn quickly and work independently
