Clinical Study Administrator
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTENs Pharma team in Gothenburg is searching for a Clinical Study Administrator for a consultancy assignment at AstraZeneca in Mölndal.
About AstraZeneca:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
To Study Operations in Early Clinical Development, IMED, we are looking for a Clinical Study Administrator for a 6 months period.
The Arena:
Early Clinical Development is a dedicated clinical scientific resource for AstraZeneca's early development portfolio, which provides a translational medicine capability to rapidly understand the disease target and the potential of our candidate drugs in humans. Within Early Clinical Development the Study Operations organization is responsible for the delivery of planned clinical trials in accordance to agreed timelines.
Tasks and responsibilities/The role:
The Clinical Study Administrator is accountable for assisting the Associate Director Study Management (ADSM) and the Study Management Associate(s) fulfil their accountabilities through coordinating activities that ensure quality and consistency and providing administrative support. The Clinical Study Administrator will work across several clinical studies. The exact accountabilities will differ depending on the exact nature of the clinical programme so a high degree of flexibility is required.
Typical accountabilities:
• Collect, review and track relevant clinical documents, as required by the study.
• Support maintenance of the Trial Master File (TMF).
• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, ANGEL, Sharepoint, BOX) and support others in the usage of these systems
• 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 and contribute to the preparation of internal and external meetings
• Contribute to and distribute presentation material for meetings, newsletters and web-sites
Minimum requirements:
• University degree
• Basic understanding of the drug development process
• Basic knowledge of ICH-GCP principles
• Fluent in written and spoken English
A clear demonstration of behaviours of:
• Ability to prioritise
• Flexibility
• Ability to manage multiple deliverables
• Team oriented
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 Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-10-16ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-23
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 4404327
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