Study Management Associate, Early Clinical Development
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige We are now recruiting a Study Management Associate (SMA) to join the Study Operations team within Early Clinical Development at AstraZeneca in Gothenburg, Sweden.
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.
As a SMA you will work close to Associate Directors Study Management and Senior Study Management associate and be responsible for coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes. The exact responsibilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required. The SMA is a global role and therefore you could work in studies within all therapeutic areas where AstraZeneca operates.
Main Duties and Responsibilities
* Contribute to the development and update of study documents as well as review of SOPs and guidance documents
* Lead the preparation of country specific agreements confidentiality agreements, clinical trial applications and other applicable country documents.
* Ensuring the adequate and prompt supply of study materials and investigational products by liaising with Investigational Product Supply and external service providers as appropriate.
* Maintain and close the TMF, ensuring continual inspection readiness
* Support the study delivery team in the implementation of audits and regulatory inspections.
* Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
* Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents
* Initiate and maintain production of study documents, ensuring template and version compliance.
* Provide input to data management, and interface with data management representatives and sites to facilitate the delivery of study data
* Prepare presentation material for meetings, newsletters and web-sites
Essential Requirements
* University degree in relevant discipline, preferably in medical or biological science, or discipline associated with Clinical Research or equivalent
* Good understanding of the drug development process, study management, drug handling and data management
* Experience of working with and delivering through strategic partners and 3rd party vendors
* Excellent knowledge of International Conference on Harmonisation (ICH)-GCP and basic knowledge of GMP/GDP
* Fluent in written and spoken English
* A clear demonstration of behaviours of: Ability to prioritise, flexibility, ability to manage multiple deliverables, team oriented, ability to manage change and actively seek and champion more efficient and effective methods/processes, good communication, negotiation, collaboration and interpersonal skills
If you are interested, apply today!
For more information about the position please contact recruiting manager Sven Anders Benjegård at +46 722 035 308
Welcome with your application no later than September 28, 2018. Interviews will be held continuously, so please submit your application at your earliest convenience.
AstraZeneca is a global, innovation-driven biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. In addition to being one of the world's leading pharmaceutical companies, AstraZeneca is proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity.
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
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-09-09ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-09-28
Ange följande referens när du ansöker: R-035395
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
ulrica.marklund1@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4336762
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