Ref #: 25164

Employment type: Permanent - Full-Time

Location: UK - Home-based

Posted: 14-Nov-2020

Description

Global Study Associate (GSA)

Job Description

The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Senior Global Study Leader (SrGSL), Global Study Leader (GSL) 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), Standard Operating Procedures (SOPs), policies & best practices and values & behaviours.

Typical Accountabilities

• Support the SrGSL, GSL and/or GSM by completing delegated study work as required. May work across many different studies and delivery models concurrently.
• Set-up, maintain and close of the Trial Master File (TMF)as delegated by the GSL/SrGSL. Ensure compliance to ICH-GCP and SOPs.
• Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.
• Oversee the collection, review and track relevant study documents in TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• Contribute to and distribute meeting material and other varied forms of communication.
• 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. Collate the administrative appendices for the Clinical Study Report.
• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.
• Support the SrGSL/GSL with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. iBUY).
• Maintain internal & external contact lists to facilitate communications among updated personnel.
• Manage access to various study systems (e.g. EDC, CTMS, SharePoint, IxRS, MS Teams etc.).
• Manage and contribute to the coordination, supply and tracking of study materials and equipment.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to policies and SOPs. Support inspection readiness activities as required throughout the course of the study.
• Lead the practical arrangements and contribute to the preparation of internal and external meetings.
• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular system or tool within Study Management Early.

Education, Qualifications, Skills and Experience

Essential

Administrative knowledge and basic knowledge in drug development and ICH-GCP
Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Ability to prioritize appropriately and to be adaptable
• Computer proficiency in day-to-day tasks
• Excellent verbal and written communication in English
• Demonstrate ability to work independently, as well as in a team environment

Desirable

• Right-to-work in the UK
• Education in medical or biological sciences or discipline associated with clinical research - Bachelor’s Degree (or higher)
• Study administration experience
• Experience within the pharmaceutical industry
• Experience in supporting clinical trials and study development

Key Relationships to reach solutions

Internal

• Senior Global Study Leader, Global Study Leader, Global Study Manager
• Associate Director Study Operations
• Study Management Early group
• Early RIA & Early CVRM groups
• Study Physician
• Statistics, Programming & Data Management
• Global Regulatory Affairs
• Patient Safety
• Procurement
• Quality Assurance
• Supply Chain
• Other Development Operations functions (ex. Site Management & Monitoring, Enablement, Clinical Trial Transparency, etc.)
• Other functional representatives in the study team

External

• External service providers (ex. CRO, suppliers, etc)
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