• Plans, manages, and requests resource as required for assigned studies.
• Maintaining a consistent, manageable workflow for Data Management project team by monitoring enrolment information and communicating with project team to actively influence data collection.
• Ensuring work carried out under the DM Alliance is in accordance with SOP’s and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area.
• Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.
• Leads development of Data Review and Oversight Plans; contributes to other key study level documents (e.g., protocols, SAPs).
• Creates and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms and sign-off on all data management plan (DMP) documents.
• Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided.
• Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry and reporting of clinical data.
• Develops test scripts and execution logs for User Acceptance Testing (UAT) and performed UAT on forms and edits for new studies in the Development phase.
• Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
• Validation and verification experience of EDC systems.
• Testing and validating study specific Electronic Data Capture System (EDC).
• Defining necessary validations or reports to ensure quality and timeliness of data collection.
• Working in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection.
• Mentor junior level staff on database management tasks and processes.
• Ensuring all DM procedures executed with a high attention to detail, accuracy, and timelines.
• Representing the DM function on project teams.
• Proven leadership and expertise in a specific CDM task or technology.