Study Management Associate - Early Clinical Development
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
2018-09-20
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hela Sverige ALTEN Pharma in Gothenburg is searching for you who wants to take on an exciting consultancy assignment at AstraZeneca in Mölndal:
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 ALTEN:
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-09-20ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-09-24
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4358400
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