Dr. Falk Pharma GmbH
Freiburg, Germany
Your tasks
Contact person for the study teams and external clinical trial service providers (CROs) for data management and biostatistics
Ensure that CROs' SOPs and other process documents for data collection, processing and evaluation in Phase I to III clinical trials meet regulatory requirements and that agreed quality standards and deadlines are met
Defining the strategy for the statistical analysis of clinical trials together with the study team and the CRO
Review of the statistical parts of the study protocol, the statistical analysis plan, the study report, as well as data management and validation plans and data protection impact assessment, collaboration on dossiers for market approval and/or product reimbursement (value dossier)
Review and approval of relevant documents regarding data acquisition tools (eCRF, eCOA, ePRO, IRT) for clinical studies and conduct of user acceptance tests
Review and release of CDISC packages
Risk-based review of...