AstraZeneca
GlobalStudyAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Study Associate at AstraZeneca. Skills: eTMF management, Document compliance, Stakeholder coordination. Support Global Study Leaders (GSL) and Global Study. Complete delegated study work”
Industry & Context.
Organizational skills; Analytical skills
What They're Looking For.
Must Have
Previous administrative training/experience, Computer proficiency in day-to-day tasks, Excellent verbal and written communication in English, Ability to prepare presentation materials, Demonstrate professionalism and mutual respect, Willingness and ability to train others on study administration procedures, Excellent organization and time management skills, Excellent attention to detail, Ability to multi-task in a high volume environment with shifting priorities
Nice to Have
Education in medical or biological sciences or discipline associated with clinical research preferred
What You'll Do.
Support Global Study Leaders (GSL) and Global Study
Complete delegated study work
Initiate and lead the set-up of the electronic
Ensure compliance to International Conference of Harmonisation Guidelines
Interact/collaborate with Site Management & Monitoring
Interact/collaborate with other internal staff
Interact/collaborate with external vendors
Collect regulatory documents
Collect other essential documents
Contribute to electronic applications/submissions in ANGEL
Create clinical-regulatory documents
Manage clinical-regulatory documents
Support effective publishing and delivery to regulatory authorities
Plan and collate the administrative appendices for the
Initiate production of study documents
Maintain production of study documents
Ensure template and version compliance per study specific
Set-up AstraZeneca tracking and communication tools
Populate AstraZeneca tracking and communication tools
Accurately maintain information in AstraZeneca tracking and communication
Support team members in the usage of these
Support the set-up of Clinical Trial Transparency (CTT)
Support the maintenance of Clinical Trial Transparency (CTT)
Support the close-out of Clinical Trial Transparency (CTT)
Coordinate with relevant stakeholders to fulfil AstraZeneca compliance
Coordinate with relevant stakeholders to meet regulatory authority
Support the GSL/GSAM with tracking the study budget/payments
Support the GSL/GSAM with reconciliation of the study
Support the GSL/GSAM with follow-up of the study
Contribute to application of study materials and equipment
Contribute to coordination of study materials and equipment
Contribute to supply of study materials and equipment
Contribute to tracking of study materials and equipment
Contribute to collection of study supplies at study
Coordinate administrative tasks throughout the conduct of the
Coordinate logistic support throughout the conduct of the
Coordinate administrative tasks during audits
Coordinate logistic support during audits
Coordinate administrative tasks during regulatory inspections
Coordinate logistic support during regulatory inspections
Lead the practical arrangements coordination for internal meetings
Lead the practical arrangements coordination for external meetings
Contribute to the preparation of internal meetings
Contribute to the preparation of external meetings
Liaise with internal participants
Liaise with external participants
Prepares presentation material for meetings
Contribute presentation material for meetings
Distribute presentation material for meetings
Prepares presentation material for newsletters
Contribute presentation material for newsletters
Distribute presentation material for newsletters
Prepares presentation material for web-sites
Contribute presentation material for web-sites
Distribute presentation material for web-sites
Work on non-drug project work in process improvements
Lead improvement projects as discussed and agreed upon
How You'll Work.
Team & Collaboration
Interact/collaborate with Site Management & Monitoring; Interact/collaborate with other internal staff; Interact/collaborate with external vendors; Support team members in the usage of these tools; Coordinate with relevant stakeholders; Liaise with internal participants; Liaise with external participants; Liaise with vendors
Communication Scope
Verbal communication; Written communication; Presentation material preparation
Process & Methodology
Process improvements, Improvement projects
Full Job Description
Typical Accountabilities: \- Support Global Study Leaders (GSL) and Global Study Associate Manager (GSAM) 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. VCV/VQV, 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 GSL/GSAM with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. Accord, Coupa, 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
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