Clinical Development Associate Manager for AstraZeneca
Poolia Sverige AB, Poolia Väst AB / Apotekarjobb / Mölndal
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hela Sverige On behalf of AstraZeneca we are now looking for Clinical Development Associate Manager.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services.
The assignment will start immediately and go on until 2016-12-31 with possibility for extension. Interviews and selections are held continuously so please apply today!
Assignment
The Clinical Development Associate Manager will participate in the coordination of and contribute to operational activities that ensure quality, consistency, and integration of study data.
Here is a selection of accountabilities and Responsibilities:
• Coordinate operational aspects of AZ late-phase studies from SS/Proposal through CSR/Publication.
• Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
• 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
• Provide input into non-drug project work including training activities, and development of procedures as needed
• Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools
• Ensure the supply of study materials and Investigational product liasing with Investigational Product Supply or external service providers as appropriate
• Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
• 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, to and resolving with the Study Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
Requirements
The role of a Clinical Development Associate Manager is intended for someone who is ha sWillingness to travel both domestically and internationally. Someone who has good communications skills in Swedish and English, both written and verbal. The role is intended for someone who has good understanding of Clinical data flow, The ability to develop advanced computer skills to increase efficiency in day to day tasks, the ability to multitask and demonstrates ability to work independently, as well as in a team environment.
• Relevant experience of operational activities within a late phase study team.
• Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
• Relevant industry or health care experience
• Proven organizational and analytical skills
• Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities
• Computer proficiency
• Excellent knowledge of spoken and written English. Good knowledge in Swedish is appreciated but not a demand.
Varaktighet, arbetstid
100%. Tillträde: Omgående Visstidsanställning
Publiceringsdatum2016-02-10ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-03-10
Ange följande referens när du ansöker: 660997
Klicka på denna länk för att göra din ansökanKontaktSara Jägevall
sara.jagevall@poolia.seFöretagPoolia Sverige AB, Poolia Väst AB
AdressPoolia Sverige AB, Poolia Väst AB
Kungsgatan 57 A, Box 207
10124 Stockholm
KontorsadressKungsgatan 57 A, Box 207
Jobbnummer 2663323
Observera att sista ansökningsdag har passerat.