AstraZeneca Pharmaceuticals LP Global Study Associate in Warsaw, Poland
Global Study Associate/ GSA is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) 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 Leader (GSL) and Global Study Associate Managers (GSAM) 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.
Support Global Study Leaders (GSL) and Global Study Associate Managers (GSAMs) by completing delegated study work.
Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.
Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR
Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools
Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs
Support the Global Study Leader with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. iBUY, FIND)
Contribute to application, coordination, supply and tracking of study materials and equipment.
Contribute to collection of study supplies, if required, at the study close-out
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 web-sites
Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Education in medical or biological sciences or discipline associated with clinical research preferred;
Proven organizational and analytical skills
Previous administrative training/experience
Computer proficiency in day-to-day tasks
Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
Excellent verbal and written communication in English
Demonstrate ability to work independently, as well as in a team environment
Ability to prepare presentation materials
Demonstrate professionalism and mutual respect
Willingness and ability to train others on study administration procedures
Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.