Study Management Associate
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige We are now looking for a talented Study Management Associate (SMA) to join the Study Operations team within Early Clinical Development at AstraZeneca Gothenburg for a 6-months consulting assignment starting as soon as possible. Warmly welcome to Poolia and AstraZeneca Gothenburg. If you are interested, apply now!
About the consulting assignment
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 ICH-GCP and basic knowledge of GMP/GDP
• Fluent in written and spoken English
• A clear demonstration of behaviors of: Ability to prioritize, 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
About AstraZeneca
AstraZeneca is a global, science-driven biopharmaceutical company. We turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them. 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.
If you are interested, apply now!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-11-07ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-11-25
Ange följande referens när du ansöker: 51386
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4445582
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