Study Management & Monitoring Associate, Early Clinical Studies
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige We are now recruiting a Study Management and Monitoring Associate (SMMA) to join the Study Operations team within Early Clinical Development (ECD) at AstraZeneca in Gothenburg, Sweden.
ECDis 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 ECD the Study Operations organization is responsible for the delivery of planned clinical trials in accordance to agreed timelines.
The SMMA is accountable for assisting the Senior Study Management Associate and Associate Directors Study Management to fulfill their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required. A portion (<50%) of the role also involves managing the set-up and monitoring of clinical sites, as the individual will be assigned as the Clinical Research Associate (CRA) for specific sites.
Main Duties and Responsibilities
* Contribute to the development and update of study documents as well as review of SOPs and guidance documents
* Ensuring the adequate and prompt supply of study materials and investigational products across the study and at sites where the individual is assigned as the CRA, by liaising with Investigational Product Supply and external service providers as appropriate.
* 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
* When assigned CRA for specific sites, responsibilities include to maintain the Investigator Study File (ISF) as well as maintaining and close the Trial Master File (TMF) ensuring continual inspection readiness at study, country and site level.
* Initiate and maintain production of study documents, ensuring template and version compliance. Providing input to data management, and interface with data management representatives and sites to facilitate the delivery of study data
* Contributing to and ensuring timely preparation of site financial agreements and country specific Clinical Study Agreement (CSA), confidentiality agreements, clinical trial applications, the local monitoring plan and other applicable operational documents.
* Leading the set-up of assigned study sites, including contribution to selection of potential investigators, site qualification visits, site contacts, and timely collection of site study documents for regulatory / ethical submission.
* Monitoring assigned clinical sites to AstraZeneca Procedural documents and international guidelines such as ICH-GCP, as well as local regulations,
* Train and support site staff on study procedures, and drive site performance and recruitment. Perform source data verification as per the study monitoring plan, ensure data query resolution by the site in collaboration with data management, and ensure timely and accurate reporting of Serious Advere Events (SAEs).
Essential Requirements
* University degree in related 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 directly with sites, preferably as a CRA.
* Ability to travel to sites for monitoring duties
* 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 behaviours of: Ability to prioritise, 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
If you are interested, apply now!
For more information about the position please contact recruiting manager Sven Anders Benjegård at +46 722 035 308.
Welcome with your application no later than April 19, 2018.
AstraZeneca is a global, innovation-driven biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. In addition to being one of the world's leading pharmaceutical companies, 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 and will consider all qualified applicants for employment without discrimination.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-03-28ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-04-18
Ange följande referens när du ansöker: R-025237
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
ulrica.marklund1@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4049815
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