Freelancer / Consultant / EDC Developer / Clinical Programmer

* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC) * Creation of electronic case report forms (eCRFs) * Validation of programs, edit checks * Write validation test scripts * Execute validation test scripts * Write custom functions * Implement study build best practices * Knowledge of the process of clinical trialsContinue reading “Freelancer / Consultant / EDC Developer / Clinical Programmer”

Data Management Plan in Clinical Trials

  The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning. The data management plan typically contains the following items. They are: Introduction/Purpose of the document Scope of application/Definitions Abbreviations Who/what/where/when Project Schedule/Major Project Milestones Updates of the DMP Appendix The objective of thisContinue reading “Data Management Plan in Clinical Trials”

Role of Project Management and the Project Manager in Clinical Data Management

  The Project Manager is responsible for the development, oversight of implementation, and communication of clinical research studies. So what is a Project? A project is a work effort with a definite beginning and end, an identifiable end result (deliverable), and usually has limits on resources, costs and/or schedule. What is Project Management? The applicationContinue reading “Role of Project Management and the Project Manager in Clinical Data Management”