Senior Clinical Data Manager/Principal Clinical Data Manager

Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices

Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues Perform other duties as assigned