Study Delivery Administrator

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.



As the Study Delivery Administrator (SDA) you will assist in the coordination and administration of the interventional study activities and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

For SDA with verified long experience, consistent high performance of the individual during several years, independent execution of all work tasks and verified advanced study administrative support the position will be entitled Senior SDA



Major Responsibilities

* Assist in coordination and administration of clinical studies from the start-up to execution and close-out
* Collect, assist in preparation, review and tracking of documents for the application process (HA/IEC). Interface with Investigators, external service provider, CRAs and Lead CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs, Lead CRAs and/or the CPL until finalization of the study.
* Operational responsibility to set-up the local Trial Master File (eTMF) and 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 CRAs in the maintenance and close out activities for the ISF.
* Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
* Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
* Contractual support of study delivery, suggests appropriate payment by investigator and supports in negotiations with sites and investigators
* Ensures HCP payments are made in compliance to regulations
* Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors
* Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites
* Responsible for layout and language control, copying and distribution of documents. Support with local translation in Sweden and spell checks in English to/from Swedish
* Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study related e-mails
* Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents (global studies)



Minimum Requirements / Preferred Background

* 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.
* Proven organizational and administrative skills
* Very good spoken and written English



Skills and Competencies

* 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 skills
* Good interpersonal skills and ability to work in a global 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





More information

For more information regarding the position please contact Annabelle Zaar Hedin 070 3111690.

Please send your application as soon as possible or no later than September 30th, applications will be handled on a current basis.



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.