Global Study Associate Oncology - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Location:
Barcelona - On-Site

The GSA is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP)development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSA supports Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g.

ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

Typical Accountabilities

Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global StudyManagers (GSMs) by completing delegated study work.

Initiate and lead the set-up of the electronic Trial Master File (eTMF).

Maintain and close theeTMF to ensure compliance to International Conference of Harmonisation Guidelines for GoodClinical Practice (ICH/GCP) and AZ SOPs.

Interact/collaborate with Site Management & Monitoring, other internal staff and externalvendors in collection of regulatory and other essential documents.
Initiate and maintain production of study documents, ensuring template and versioncompliance per study specific requirements.
Setup, populate and accurately maintain information in AstraZeneca tracking andcommunication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team sharedmailbox) and support team members in the usage of these tools.
Support the setup, maintenance and closeout of Clinical Trial Transparency (CTT) activity inPharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meetthe regulatory authority needs.

Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. iBUY, FIND).

Contribute to collection of study supplies, if required, at the study closeout.
Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.
Prepares, contribute and distribute presentation material for meetings, newsletters and websites.
Work on nondrug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Education, Qualifications, Skills and Experience

Essential:

Education in medical or biological sciencesor discipline associated with clinicalresearch preferred;
Proven organizational and analytical skills
Previous administrative training/experience
Computer proficiency in daytoday tasks
Develop working knowledge of the ClinicalStudy Process and an understanding of therange of working procedures relating to it,together with an understanding of theICH/GCP guidelines
Excellent verbal and writtencommunication in English
Demonstrate ability to work independently,as well as in a team environment
Ability to prepare presentation materials
Demonstrate professionalism and mutualrespect
Willingness and ability to train others onstudy administration procedures
Display excellent organization and timemanagement skills, excellent attention todetail, and ability to multitask in a high

- volume environment with shifting priorities.

Desirable