Job Description
The Senior Clinical Data Manager/Principal 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.
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.
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. The role includes liaising with third-party vendors, identifying and troubleshooting operational problems, reviewing protocols, and contributing to SOP development.
About Precision Medicine Group
Precision Medicine Group is an Equal Opportunity Employer where employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, etc.