BP SMO Global Study Associate

AstraZeneca; Warszawa; On-site; PLN 90,000 - 120,000; Full time

Job summary

AstraZeneca in Warszawa is seeking a study administration specialist to support GSAD and GSMs across multiple studies, ensuring compliant document management and efficient study operations.

The role requires strong organizational and analytical skills, English fluency, and the ability to work independently or with a team. You will help prepare materials for meetings and contribute to process improvements.

Qualifications

• Proven organizational and analytical skills.
• Background in medical/biological sciences preferred.
• Experience with administrative training or roles.
• English communication, both written and verbal.
• Ability to work independently and in a team.
• Ability to prepare presentation materials.

Responsibilities

• Support GS(A)D and GSMs by completing delegated study work.
• Lead eTMF set-up and ensure compliance with ICH/GCP and AZ SOPs.
• Collaborate with internal staff and external stakeholders to collect regulatory documents.
• Create and manage regulatory documents in ANGEL for submissions and CSR appendices.
• Maintain information in AstraZeneca tracking tools and support usage.
• Support CT transparency activity in PharmaCM and coordinate with stakeholders.
• Track study budget/payments across systems.
• Coordinate study materials and equipment logistics through study close-out.
• Coordinate administrative tasks throughout audits and inspections.
• Lead meeting arrangements and liaise with participants and vendors.
• Prepare and distribute presentation material for meetings and newsletters.
• Contribute to non-drug process improvement projects.

Skills

Organizational skills

Analytical skills

Teamwork

Independent working

Presentation material preparation

Professionalism

Training others

English communication

Education

Bachelor level education

Education in medical or biological sciences

Job description

Responsibilities

• Support GS(A)D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently.
• 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 internal staff and external stakeholders 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 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 GS(A)D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems.
• 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.
• Prepare, contribute and distribute presentation material for meetings, newsletters and websites.
• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements

Essential

• 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

Desirable

• Bachelor level education (or higher)
• Proven study admin/assistant or relevant experience on a study level
• Experience in clinical study lifecycle

AstraZeneca embraces diversity and equality of opportunity.

We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

We believe that the more inclusive we are, the better our work will be.

We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.