Clinical Study Administrator
Background & Qualifications
- University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
- Good knowledge of spoken and written English
- Previous administrative experience preferably in the medical/ life science field is an advantage
- Strong communication and negotiation skills,
- Ability to prioritize and handle multiple tasks,
- Effective planning and organizational skills with a result-oriented approach,
- Analytical thinking, critical reasoning ability,
- Good command of MS Office applications,
- No military obligation for male candidates.
- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process.
- Operational responsibility for the correct set-up and maintenance of the local archiving systems and ISF including document tracking in accordance with ICH- GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the related archiving systems “Inspection Readiness”.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance
- Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards.
- Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools.
- Manages and contributes to coordination and tracking of study materials and equipment.
- Close communication & colloboration with local& global study teams.
- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.