Clinical Data Manager
Cancer Insight Clinical Data Manager is responsible for executing data management activities from study start through closure, to include data collection, tracking and cleaning, study material development, study closeout activities, and vendor liaison.
This is a remote, work from home position.
Roles and Responsibilities
▪ Critically review protocols and provide feedback as it pertains to data collection and data management activities
▪ Contribute to the design of study databases, case report forms (CRFs) and edit checks
▪ Perform User Acceptance Training (UAT)
▪ Develop and maintain proper study documentation throughout the lifecycle of a study, to include, but not limited to DMP, eCRF Completion Guidelines, Database Specifications, Edit Check Specifications, UAT Test Plan
▪ Create and validate standard, study-specific, and ad hoc study reports
▪ Develop training material and provide EDC training for internal users and site personnel
▪ Perform quality control review checks
▪ Perform SAE reconciliation between EDC and safety database
▪ Perform medical coding
▪ Ensure that all data management activities leading to database lock are completed; work with clinical team as needed to ensure timely database lock.
▪ Perform data transfers from EDC to sponsors
▪ Interact with third-party vendors, such as central laboratories, to carry out data management tasks
▪ Communicate project statuses and key issues to director
▪ Participate in cross-functional team meetings as requested
▪ Other duties as assigned
Personal and Professional Qualifications
▪ 1-4 years of clinical trial data management experience in biopharma or CRO
▪ Knowledge of industry standards, such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines
▪ Experience with clinical databases such as Medrio, OpenClinica, Oracle
▪ Strong understanding of clinical trial processes and EDC platforms
▪ Proficient in Microsoft Excel, Word, PowerPoint and GSuite Applications
▪ Excellent verbal and written communication and organizational skills
▪ A high degree of flexibility and willingness to take on non-traditional CDM tasks
Education Bachelor's degree or equivalent combination of education/experience in math, science, or health-related field.