At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Study Administrator in Wilmington, DE you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
As a Study Administrator, you will assist in the coordination and administration of the interventional study activities and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
Your key responsibility will be, operationally, to set-up the local Trial Master File and Investigator Study File (ISF), including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
- Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, completed high school and further studies in administration.
- College degree preferred
- Previous administrative experience
- Proven organizational and administrative skills
- Computer proficiency
- Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
- Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
- Good verbal and written communication
- Good interpersonal skills and ability to work in an international team environment
- Willingness and ability to train others on study administration procedures
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
- Integrity and high ethical standards
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.