Sara Idris

Background

About Sara Idris

Clinical Trial Associate (CTA) – Boehringer Ingelheim (BI) CTA in BI, I had responsibility for adequate administrative, logistic and operational support within Clinical Operations and/or to clinical trials from start-up until completion, within defined timelines and in accordance with ICH-GCP and/or other ethical and regulatory requirements. Below I have listed some of my accountabilities- Prepare relevant documents for the trial team- Coordinate, collect, control and registration of essential documents- Keeping overview on the essentials documents- Support in contract management- Support in translate/back translate of trial documents e.g labels, ICF. Competences gained • Processing and analyzing information • Team work • High ethical standards • Ability to work in a highly regulated and performance-monitored environment. • Accurate (attention to detail) QA/IT Validation Manager (VM) – BI As QA/IT VM I had responsibility for ensuring that all system lifecycle (SLC) documents are in place prior to operating the system. Additionally, I was responsible to initiate the according activities to comply with all BI standard operating procedures (SOP). Acts as VM- Ensure the validation status and the SLC management by creating and reviewing documents, setting up change controls, executing documented tests, contacting system owners- Provides first level support (trains/ advises users)- Ensures that open issues i.e discrepancies, CAPA etc are closed in timely manner- Ensure that the validation status of the system is in operation- Contribute to general QA tasks in BI to ensure GMP compliance. Competences gained • Knowledge in CSV & C (Computerized System and Compliance) and System Life Cycle Management. • Computer System validation • Project Management skills • Knowledge in Quality processes • Good communication skills within/across different departments • GxP Contact information: E-mail: Sara88_6@hotmail.com Mobile:+45 27 20 73 50