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Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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Clinical Development Associate Manager - CDAM
We are now recruiting a CDAM working as a consultant at AstraZeneca Mölndal. The assignment starts May 2nd until December 31th.
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.
Business: Dfind Science & Engineering
City: Göteborg
Omfattning: Heltid
Deadline for applications: 2016-02-17.
More information: Birgitta Nyström,
birgitta.nystrom@dfind.se .
Qualification:
• 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
Minimum Requirements -Education and Experience
• 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.
Skills and Capabilities
• Develops leadership capabilities to facilitate effective global working with a cross functional team environment
• Good understanding of Clinical data flow.
• The ability to develop advanced computer skills to increase efficiency in day to day tasks
• 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
• Good interpersonal skills and ability to work in a team environment
• Willingness to travel both domestically and internationally
• Demonstrates sound knowledge of GCP and AZ procedural documents as they pertain to study delivery systems and processes
• Proactively identifies risks and issues and possible solutions
• Demonstrates analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity, conflict resolution skills, and the ability to influence others
• Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas
• Demonstrates ability to prepare and deliver study related training materials
• Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
• Demonstrates professionalism and mutual respect
• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
Organization/Business description:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag specialiserade på kompetenser inom naturvetenskap och teknik. Med engagemang och lyhördhet hjälper vi människor och företag att hitta lösningar för att utvecklas. Hos oss har du möjlighet att utveckla dina kunskaper och färdigheter genom uppdrag hos våra utvecklings- forsknings- och produktionsintensiva kunder i Norden. Vi tycker att det är viktigt att all kompetens på arbetsmarknaden tillvaratas. Vi välkomnar alla sökande och eftersträvar mångfald. Dfind Science & Engineering ett auktoriserat bemanningsföretag via Almega och följer deras kollektivavtal.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-02-10ErsättningFast lön
Så ansöker duSista dag att ansöka är 2016-02-16
Ange följande referens när du ansöker: 200877277
Klicka på denna länk för att göra din ansökanKontaktBirgitta Nyström
birgitta.nystrom@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 2663127
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