Clinical Development Associate Manager
AstraZeneca Mölndal / Apotekarjobb / Mölndal
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world?s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The arena
AstraZeneca has a vision to improve the lives of 200 million patients by 2025. One very important part on that journey is to setup and deliver clinical studies to test a new drug. The Clinical Development Associate Manager (CDAM) is playing an important role in the coordination of operational activities within the study to make this happen.
You will participate in the coordination of a clinical study to ensure quality, consistency, and integration of study data and progress deliverables to time, cost and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR).
The role
• Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic Clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives
• Implement globally agreed Operations and Clinical Development strategies including processes and use of technical systems related to operational delivery
• Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
• Provide input to data management documents (e.g. Case Report Form, Data Management Plan)
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and in the development of the Source Data Verification (SDV) plan and other applicable Operations documents
• Ensure the supply of study materials and Investigational product liasing with Investigational Product Supply or external service providers as appropriate
• Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meetings, Investigator Sponsored Study Review)
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives.
Preferred experience/requirements
• Good project management skills, including risk and opportunity management
• Strong leadership skills in order to engage people, to promote and facilitate team accountability and stakeholder management
• Seeks and makes creative connections between internal and external trends to identify and implement opportunities to enhance the business
• Good understanding of Clinical data flow.
• Excellent verbal and written communication and presentation skills
• Demonstrates ability to work independently, as well as in a team environment
• Ability to prioritize and manage multiple tasks with conflicting deadlines.
More information
Welcome with your application, via
www.astrazeneca.se , in English no later than May 17.
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2015-04-30ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-05-17
Ange följande referens när du ansöker: MOL000001R6
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2274690
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