Project Support Specialist II

Accountabilities:

Coordinate the complete lifecycle of internal and external project meetings, including scheduling, preparing agendas, recording and distributing minutes, incorporating feedback, and maintaining documentation within the Trial Master File (TMF).
Support the creation and maintenance of project timelines using MS Project or similar tools, collecting progress updates from team members and communicating changes to relevant stakeholders.
Perform administrative and operational activities across clinical systems in accordance with project requirements and assigned responsibilities.
Coordinate study-specific training activities by collecting and distributing materials, assigning training, tracking completion, maintaining records, and identifying compliance gaps for escalation.
Establish and maintain study collaboration spaces, including SharePoint sites, shared folders, and project-specific email accounts, ensuring appropriate access for internal teams and external stakeholders.
Manage user access to clinical study systems, including submitting access requests, conducting periodic reviews, documenting changes, and ensuring timely removal of access when team members leave a project.
Coordinate study supplies, prepare study binder materials, liaise with external vendors, obtain cost estimates, and verify invoices and payments in collaboration with Project Managers.
Maintain project trackers, financial records, team member assignments, and time-reporting processes, reviewing weekly submissions and escalating discrepancies when necessary.
Support the distribution and tracking of clinical safety documentation, including IND Safety Reports, SUSARs, and CIOMS, under the guidance of the Safety Lead and in accordance with study procedures.
Coordinate the translation of site-level documentation by collecting materials, tracking progress, liaising with translation vendors, reviewing completeness with stakeholders, and supporting payment processes.
Assist with vendor management activities, including preparing vendor management plans, coordinating training and system access, tracking issues, and monitoring invoices and payments.
Coordinate the preparation, distribution, and reconciliation of study materials, such as operations manuals, Investigator Site Files (ISF), and patient cards.
Support Project Managers and other study leaders in preparing project plans, reports, and updates related to country and site initiation, activation, recruitment, and overall study progress.
Collect and maintain monthly Key Performance Indicators (KPIs) and project health data, sharing relevant updates with project leadership and internal stakeholders.
Gather functional team input for quarterly inspection readiness reviews and support the maintenance of sponsor-facing project dashboards and study storyboards.
Assist with tracking out-of-scope activities and preparing supporting documentation for change order submissions.
Take on additional project coordination and administrative responsibilities as required to support successful study delivery.
Requirements:
Bachelor's degree or international equivalent, preferably in business, science, healthcare, or a related discipline. Equivalent professional experience may also be considered.
At least 2 years of relevant professional experience or demonstrated competencies in project support, clinical research coordination, or related operational functions.
Professional fluency in English, with strong written and verbal communication skills to collaborate effectively with international teams and stakeholders.
Advanced working knowledge of Microsoft Office applications, particularly Outlook, Word, Excel, and PowerPoint.
Working knowledge of International Council for Harmonisation – Good Clinical Practice (ICH-GCP), standard operating procedures (SOPs), and applicable regulatory guidance.
Strong organisational and administrative skills, with the ability to coordinate multiple priorities, maintain accurate documentation, and meet deadlines.
Excellent attention to detail and the ability to identify inconsistencies, follow established procedures, and maintain high-quality project records.
Strong interpersonal and collaboration skills, with a customer-service-oriented approach and the ability to work effectively across cross-functional teams.
Ability to work independently, exercise sound judgment, and demonstrate initiative while knowing when to seek guidance or escalate issues.
Adaptability, self-motivation, and a proactive approach to managing changing priorities in a dynamic, international environment.
Benefits:
Opportunity to contribute to international clinical research projects with meaningful impact on healthcare and medical innovation.
Exposure to multidisciplinary teams and collaboration with professionals across different countries and functions.
Opportunities to develop expertise in clinical project management, regulatory processes, and research operations.
Professional growth through hands-on experience supporting complex clinical studies.
Collaborative working environment focused on teamwork, quality, and continuous improvement.