Senior Global Study Management Associate

This is a fully remote position, open to applicants in Australia.

📋 Description

• Assists the Global Clinical Study Manager in the global delivery of studies, ensuring that assigned components of clinical trials are carried out to the expected quality standards, within the specified timelines and budget.

• Aids in aligning study objectives with the goals of clinical operations under the guidance of the Global Clinical Study Manager.

• Assists with vendor management for studies and other assigned management activities.

• Supports the Global Clinical Study Manager in organizing and coordinating logistics for cross-functional Clinical Study Team (CST) meetings.

• Fosters effective collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates, and other key stakeholders on a global and regional level.

• Possesses knowledge of clinical study operations, including the ability to interpret and implement regulatory and ICH-GCP guidelines.

• Develops a comprehensive understanding of global clinical trials operations under the mentorship of the Global Clinical Study Manager.

• Actively participates in GSMA task force initiatives and cross-functional projects within scope, contributing to process improvement, standardization, and implementation activities as needed.

• Creates and maintains study-level SharePoint and CST distribution lists.

• Sets up the study in relevant systems (e.g., eTMF, CTMS) and ensures that study-level information is consistently updated.

• Manages and grants access to systems appropriately throughout the study life cycle, assisting with user account management for systems used in the study.

• Aids in the development of various study plans.

• May help review study-related documents as assigned by the Global Clinical Study Manager (including Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines, and other relevant study plans and charters).

• Organizes study-specific investigator meetings under the supervision of the Global Clinical Study Manager.

• May assist in the creation and review of site feasibility assessments necessary for study participation.

• Manages and tracks essential study deliverables such as screening, enrollment, biological samples and images, data flow, and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates.

• Prepares metrics and updates on key deliverables for management based on information available in relevant systems.

• Assists in preparing study newsletters and other related correspondence (e.g., frequently asked questions, lessons learned) in collaboration with the study team.

• Aids the TMF specialist with study-level TMF creation and, as necessary, maintains the study-level TMF, including regular reviews and quality checks of TMF documents according to the study TMF QC plan.

• Supports the Global Clinical Study Manager in study drug forecasting and overall study drug supply activities in collaboration with Global Clinical Supplies.

• Assists with data cleaning activities and contributes to the follow-up of outstanding information.

• Aids the Global Clinical Study Manager in the planning and execution of the Clinical Study Report.

• Helps identify operational risks and issues, collaborating with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.

• Learns and shares best practices in clinical operations methodologies, systems, and processes with a strong focus on quality and compliance.

• Proposes improvements to enhance efficiency and quality in the work performed on assigned projects.

• May assist in the development of global study tools, working instructions, and SOPs.

• Supports the selection and setup of vendors for global outsourced activities.

• Aids in managing study budgets with responsibilities for PO setup and tracking payment invoices throughout all study lifecycles.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific or healthcare discipline*, with a higher degree preferred.

• Proficiency in the MS Office Suite, including Excel, PowerPoint, and Project.

• Knowledge of clinical operations methodologies and an understanding of the operational aspects of clinical study processes.

• Three or more years of experience in clinical research within the Biotech, Pharma, or CRO industries.

🏝️ Benefits

• Competitive compensation package, including a performance-based annual bonus scheme.

• Company shares (generous welcome grant!).

• Opportunities for in-house and external learning and development.

• Comprehensive benefits program.