Description:
The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within Biopharmaceuticals Clinical Operations, Study Management to time, cost and quality.
The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviors.
What You’ll Do
- 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 Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
- Provide oversight for non-complex, non-critical path vendors
- Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents.
- Contribute to electronic applications/submissions in regulatory information management system generically 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.
- Other duties as assigned and within scope of role
Essentials For The Role
- Education in medical or biological sciences or discipline associated with clinical research preferred
- 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
- Bachelor level education (or higher)
- Experience in clinical study lifecycle
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities.