Clinical Data Manager Test

Manage all aspects of the clinical data management process from study start-up to database lock for in-house Electronic Data Capture (EDC) trials including data management performance, metrics, quality assurance checks and communication of trial status within and outside the trial team.

• Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects
• Create / monitor timelines and ensures that all deadlines are met with quality
• Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy
• Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
• Develop and support creation of data management documentation, specifications and UAT requirements for database and test according to UAT Plan
• Create, review and revise data management documentation
• Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements
• Requirements:
• Identify project challenges and risks, and proposing appropriate and strategic solutions to issues
• Electronic data capture experience (Medidata Rave®) and working knowledge of Oncology indications
• Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials