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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. At BioPharmaceuticals Study Management Early we are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within Cardiovascular Renal Metabolism (CVRM), Respiratory & Immunology (R&I) and Infectious Disease.

We are now looking for a Global Study Administrator for a 6 months period who will join our BioPharmaceuticals R&D Study Management Early team - as a part within the Development Operations function. The position will be based on our vibrant R&D site in Gothenburg, Sweden. The position can be filled before application limit so don't wait with your application.

Role
As a Global Study Administrator, you will be joining a study team and perform coordinating activities that ensure quality and consistency and you will contribute to delivery of clinical trials through providing administrative support. You may 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 and an ability to coordinate multiple tasks.

Responsibilities
• Collect, review and track clinical documents, as required by the study
• Support maintenance of the Trial Master File (TMF).
• 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 material for meetings, newsletters and other communication platforms.

Qualification Requirements:
• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written English.

Skills & Experience
To succeed in this role, you will have demonstrated interpersonal skills with the ability to work both independently and as part of a team. You will have good experience in administrative duties and will be confident using a range of IT programs including MS Office suite, email and databases. You will be organised and take a proactive approach.

The right candidate will also have:
• Problem solving skills
• Basic understanding of the drug development process.
• Basic knowledge of ICH-GCP principles and relevant regulatory requirements
• Ability to manage and prioritise multiple deliverables
• Experience in operational support in clinical development would be desirable

Don't hesitate to contact me if you have any further questions!
[email protected]

Detta är en jobbannons med titeln "Global Study Administrator" hos företaget Poolia Sverige AB och publicerades på workey.se den 17 juni 2020 klockan 17:26.

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