Clinical Data Manager
- To perform all aspects of the data cleaning process in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)/ Working Practice Documents (WPDs).
Duties and Responsibilities:
- Support the setup of study activities such as CRF design, database design, including testing of data entry screens, and DVM creation, as required. This includes taking responsibility for accurately reporting and documenting discrepancies to the Lead Clinical Data Manager (Lead CDM). To fulfil all data management cleaning activities, in accordance with the Data Validation Manual (DVM) and/or sponsor documentation.
- May perform dictionary coding of items specified in the DVM.
- To perform all Quality Control (QC) processes as defined in the DVM.
- To ensure that all work conducted is completed to the acceptable quality in accordance with SOPs/WPDs and DVM. To ensure Case Report Forms (CRFs) are logically filed and are easily located by appropriate team members.
- To ensure all required documentation, as defined in the SOPs/WPDs and DVM, is created and filed correctly.
- To provide accurate status information of all individual work conducted daily and, at the request of the CDM management, the overall study status.
- May provide training, mentoring and work direction to junior staff.
· Bachelor's Degree, preferably in life science, informatics, statistics, nursing or equivalent education or equivalent demonstrable experience
· Minimum 2 years relevant experience in clinical research, drug development, data management, or other healthcare environment
· Proven data management skills
· Good written and communication skills
· Ability to deal effectively with sponsors and internal customers
All applicants must be based in the UK/ EU and have legal right to work as this client is unable to provide sponsorship.