This is a consultant assignment as a Clinical Study Administrator at Astra Zeneca, you will be accountable for assisting the Associate Director Study Management (ADSM) and the (Senior) Study Management Associate(s) to fulfil their accountabilities through coordinating activities that ensure quality and consistency and providing administrative support. You can also be responsible for keeping systems updated in studies with external partners.
You will work across several clinical studies. The exact accountabilities will differ depending on the exact nature of the clinical programme, so you'll need a high degree of flexibility.
• Collect, review and track clinical documents, as required by the study
• Ensure that all relevant Study documents are uploaded to Veeva Vault, our eTMF system, in a timely manner
• Support production of study documents, ensuring template and version compliance
• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools
• Manage and contribute to coordination and tracking of study materials and equipment
• Coordinate tasks during the study process, audits and regulatory inspections.
• Lead the practical arrangements, contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with participants and/or vendor
• Contribute to and distribute presentation material for meetings, newsletters and web-site.
- Basic understanding of the drug development process.
- Basic knowledge of ICH-GCP principles
- Ability to manage multiple deliverables
- Experience in operational support in clinical development would be desirable
- Good interpersonal skills
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