Clinical Study Administrator to AstraZeneca Gothenburg
Alten Sverige AB / Apotekarjobb / Göteborg
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hela Sverige About AstraZeneca
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.
This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.
As a Clinical Study Administrator, 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.
Role duties & responsibilities:
• 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.
Skills & Experience:
• 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
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Matilda Holthe at
matilda.holthe@alten.seVaraktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-04-10ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-04-17
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4725400
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