Global Study Management (Senior) Associate (Global CTA)

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.