Senior Project Support Specialist

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

📋 Description

• Oversees the complete meeting lifecycle, which includes scheduling both internal and external meetings, preparing and distributing agendas, recording meeting minutes, sharing and updating those minutes based on team feedback, and maintaining the Trial Master File with all meeting-related documents.

• Aids in the development and upkeep of the project timeline using MS Project or a similar tool. Gathers updates from team members, documents these updates, and ensures that they are communicated effectively to the cross-functional study team.

• Engages in a variety of activities and tasks within clinical systems that pertain to their role and project scope.

• Manages the training lifecycle specific to the study by gathering, tracking, and uploading training materials, assigning appropriate training to team members, and documenting the completion of study-specific training in relevant systems. Also responsible for maintaining training records and filing them in the Trial Master File.

• Identifies training gaps by periodically reviewing team member compliance and works with relevant team members to ensure all training is completed. Escalates issues to the Project Manager when necessary.

• Establishes a study-level SharePoint site or similar collaborative workspace, ensuring that the study team, sponsors, and other stakeholders have the appropriate access.

• Creates project-specific email accounts and manages access for study team members.

• Oversees user access to study systems by submitting requests to the Helpdesk or similar, regularly reviewing team member access, and documenting these reviews. Ensures prompt removal of system access for team members who are no longer part of the study.

• Procures study supplies and addresses any questions related to these supplies.

• Prepares study binder materials and collaborates with vendors to ensure proper binder creation and delivery to study sites. Works with vendors to obtain project-related cost estimates and ensures quotes align with invoices for completed binders, consulting with the Project Manager for vendor payment approvals.

• Maintains various study trackers as directed by the Project Manager, Clinical Trial Manager, or other project leaders.

• Manages the addition and removal of project team members in the finance system, including assigning team members to specific tasks for accurate time tracking.

• Reviews and approves weekly time reporting from team members, identifying and escalating any concerns to the Project Manager.

• Under the guidance of the Safety Lead, assists with the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures established by the study team in the project plan, as applicable.

• Manages the translation of site-level documents according to local and regional standards by coordinating document collection, tracking, vendor collaboration, and stakeholder engagement to assess translation completeness and vendor payments.

• Aids in the management of project-specific vendors by assisting in the development of the Vendor Management Plan, providing vendors with project training and access to necessary systems, tracking vendor issues, and overseeing invoicing and payments.

• Manages the preparation, distribution, and reconciliation of study materials during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as needed.

• Assists the Project Manager with the creation of various study plans, reports, and updates (e.g., PM plan, country/site initiation, activation, recruitment) by preparing initial drafts, coordinating team member input, and finalizing content.

• Gathers data and maintains monthly Key Performance Indicators (KPIs) and project health metrics, circulating this information to the Project Manager and relevant internal team members.

• Collects input from functional teams for the quarterly inspection readiness review.

• May assist team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).

• Supports the Project Manager in developing and maintaining the Sponsor-facing study storyboard.

• Aids the Project Manager in monitoring out-of-scope work and prepares, with guidance, the materials needed for submitting change orders.

• Performs additional duties as assigned by the Project Manager.

⛳️ Requirements

• Bachelor's degree or international equivalent; or comparable experience, ideally in business, scientific, or healthcare fields.

• At least 2 years of relevant experience or proven competencies related to the key requirements of this position.

• Proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• A customer service-oriented attitude; must exhibit flexibility, teamwork, and strong attention to detail.

• Excellent verbal and written communication skills in English.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities