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About the role
In this role your key tasks will include: - Design, build, test and release clinical databases to the production setting, including study design specifications, Users Acceptance Test (UAT) test cases and database configuration settings in support of database set-up and edit checks programming. You will work with SAS and EDC programming. - Review electronic Case Report Form (eCRF) Completion guidelines - Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up - Review and adhere to the requirements of study-specific data management documents & plans - Actively contribute/participate in study team, departmental meetings, sponsor meetings and uses analytical approach to problem solving - Collaborate with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs - Maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings etc. - Research and propose initiatives for improving efficiency - Develops and delivers applicable DM departmental trainings - Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System Requirements: To be successful you will possess: You bring a minimum of 2-5 years of relevant work experience in a clinical research and/or drug development organization combined with a degree in Life science and experience in SAS and EDC programming. Computer Science, healthcare and/or related field degree. You will be a great addition to the team when you are open and transparent, work well together and have a solution focused approach. - To be successful we are looking for the following traits and behaviors: _ - Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (loc .
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