Global Study Management (Senior) Associate (Global CTA)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Global Study Management (Senior) Associate (Global CTA) based in Australia.

This role supports the successful delivery of global clinical studies within a fast-paced, international oncology environment. You will work closely with Global Clinical Study Managers and cross-functional teams to ensure delegated study activities meet quality, timeline, and budget expectations. The position combines clinical operations, study coordination, vendor support, documentation, systems management, and data tracking. You’ll contribute to study planning and execution while helping maintain compliance with applicable regulatory requirements and ICH-GCP standards. The role offers broad exposure to global clinical trial processes and opportunities to contribute to operational improvements and standardization. You’ll collaborate with colleagues and stakeholders across regions while supporting studies through multiple stages of their lifecycle. This opportunity is well suited to an experienced clinical research professional who is organized, collaborative, detail-oriented, and motivated by improving outcomes for patients worldwide.

Accountabilities:: Support the Global Clinical Study Manager with global study delivery, ensuring delegated activities are completed according to quality standards, timelines, and budget requirements.

Coordinate the organization and logistics of cross-functional Clinical Study Team meetings and maintain effective collaboration with global and regional stakeholders.

Support study setup and ongoing maintenance across systems such as eTMF and CTMS, including study-level information, distribution lists, and user access.

Contribute to the development and maintenance of study plans, tools, working instructions, and other study documentation.

Assist with the review of clinical study documents, including protocols, informed consent forms, investigator brochures, monitoring plans, laboratory manuals, CRFs, and related materials, as delegated.

Organize investigator meetings and support site feasibility activities under the direction of the Global Clinical Study Manager.

Track key study deliverables, including screening, enrollment, biological samples, imaging, data flow, and protocol deviations, and prepare relevant metrics and management updates.

Support study communications, including newsletters, FAQs, lessons learned, and other study-related correspondence.

Support the creation, maintenance, and quality control of study-level Trial Master Files in accordance with established QC requirements.

Assist with study drug forecasting and supply activities in collaboration with clinical supplies teams.

Support data cleaning activities, follow-up of outstanding information, and preparation of the Clinical Study Report.

Identify operational risks and issues, contribute to solutions, and promote best practices that improve quality, compliance, and efficiency.

Support vendor selection and setup for outsourced activities, as well as study budget administration, purchase order setup, and invoice tracking throughout the study lifecycle.

Contribute to cross-functional initiatives and process improvement projects within the global study management function.

Provide mentoring or onboarding support to junior colleagues when required.

Requirements:

Bachelor’s degree or higher in a scientific or healthcare-related discipline; an advanced degree is preferred.

At least 3 years of clinical research experience within the biotechnology, pharmaceutical, or CRO industry.

Solid understanding of clinical operations methodologies and the operational aspects of clinical study processes.

Knowledge of applicable clinical research regulations and ICH-GCP guidelines , with an understanding of how they are applied in global study operations.

Strong proficiency with Microsoft Office applications, particularly Excel, PowerPoint, and Project.

Excellent organizational and project coordination skills, with the ability to manage multiple activities, priorities, and deadlines.

Strong attention to detail and commitment to maintaining high standards of quality, compliance, and documentation.

Analytical and data-oriented approach, with the ability to interpret study metrics and use available information to support decision-making.

Effective communication and interpersonal skills, with the ability to collaborate across functions, regions, and levels of seniority.

Proactive and results-oriented mindset, with the initiative to identify process improvements and contribute practical solutions.

Comfortable working in a global, multicultural environment and adapting to changing priorities.

Ability to demonstrate teamwork, continuous learning, accountability, and clear communication.

Limited travel may be required.

Benefits:

Market-competitive compensation package.

Performance-based annual bonus opportunity.

Company shares, including a generous welcome grant.

In-house and external learning and development opportunities.

Comprehensive benefits program.

Opportunity to work with a collaborative, supportive, inclusive, and international team.

Exposure to global clinical development and innovative oncology research.

Career development opportunities within a growing international organization.

Opportunity to contribute to clinical programs focused on improving access to innovative treatments for patients worldwide.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1