.Position Summary:The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.Position Summary:The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.Essential functions of the job include but are not limited to: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. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcingMay perform quality control of data entryProvide 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 stakeholdersMay assist in building clinical databasesConduct 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 specificationsResponsible 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
