Manager, Project Support Specialist

📋 Description

• • Join Precision for Medicine, a pioneering organization that is revolutionizing the life sciences industry by integrating cutting-edge technologies, deep scientific expertise, and operational scale to accelerate the development of life-changing therapies for patients. We are at the forefront of Oncology and Rare Disease research, making a tangible impact on global health.
• • We are seeking a dynamic and experienced Manager, Project Support Specialist (PSS) to be based remotely in Taiwan. This is a unique dual-capacity role, offering the opportunity to provide functional leadership to our Project Support team while also contributing directly as a Principal-level project team member on complex and high-profile studies.
• • As the Manager, PSS, you will be instrumental in building and leading a high-performing PSS function. Your leadership will drive the establishment of consistent standards, scalable processes, and a culture of operational excellence across the team. You will be responsible for developing, mentoring, managing, and coaching PSS staff, ensuring their skills align with Precision's rigorous quality standards and fostering their professional growth and accountability.
• • A key aspect of your role will involve ensuring that all PSS personnel adhere to the highest quality standards, maintaining strict compliance with established Standard Operating Procedures (SOPs), working guidelines, project plans, and all applicable regulatory requirements. You will actively participate in the recruitment process, including CV review and interviews, and will be responsible for the comprehensive onboarding and training of new PSS staff in collaboration with Human Resources and Clinical Training departments.
• • You will be tasked with developing robust and adaptable operational methodologies, standards, and processes specifically for the PSS role. This includes ensuring consistent and high-quality execution by all PSS personnel, verifying they have the necessary resources, training, materials, and system access to excel in their positions.
• • Your leadership will extend to developing tailored training plans, holding team members accountable for achieving training goals, and addressing any identified training needs proactively. You will meticulously manage the workload of your supervised staff, continuously assessing and adjusting assignments as required to meet project demands and team capacity.
• • Providing ongoing feedback, development, and coaching to PSS staff, including conducting formal annual performance reviews, will be a critical function. You will also serve as a mentor and trainer, imparting knowledge in clinical study monitoring and relevant regulations, including ICH-GCP Guidelines, ensuring that all monitoring and reporting standards are consistently met.
• • On the project delivery side, you will manage and oversee the entire meeting lifecycle. This includes scheduling internal and external meetings, preparing and distributing agendas, meticulously taking and circulating meeting minutes, and ensuring these are updated based on team and sponsor feedback. All meeting documentation will be accurately filed in the Trial Master File (TMF).
• • You will be responsible for creating and maintaining project timelines within designated systems, collecting updates from team members, documenting these changes, and ensuring clear communication of progress and any at-risk activities to the cross-functional study team and sponsors. Escalation of potential issues to Project Managers and Functional Leads will be a key responsibility.
• • Performing a wide array of activities within clinical systems relevant to the project scope will be essential. This includes managing and overseeing the study-specific training lifecycle, tracking and loading training materials, assigning training to team members, and documenting completion in appropriate systems, ensuring all training records are maintained and filed in the TMF.
• • You will proactively identify training gaps by regularly reviewing team member compliance and engaging with appropriate personnel to ensure timely completion. Establishing and managing study-level SharePoint sites or similar shared workspaces, ensuring appropriate access for study teams and sponsors, and creating and maintaining project-specific email boxes will also fall under your purview.
• • Managing user access to study systems, including submitting requests, conducting periodic reviews of team member access, and ensuring prompt removal of access for departing team members, is crucial for data security and compliance.
• • You will oversee the ordering of study supplies, address related queries, and manage the preparation of study binder materials, working with vendors for creation and shipping. This includes obtaining project-related cost estimates, ensuring vendor quotes align with invoices, and approving vendor submissions.
• • Maintaining various study trackers as directed by Project Managers or Clinical Trial Managers, and managing the addition and removal of project team members in the finance system for accurate time tracking, are vital administrative tasks.
• • You will review and approve weekly time reports, addressing any issues identified and escalating concerns to the Project Manager when necessary. With oversight from the Safety Lead, you will manage the distribution and tracking of IND Safety Reports/SUSARS/CIOMS as per study procedures.
• • Overseeing the translation of site-level documents, engaging with vendors and stakeholders to ensure completeness and manage payments, will be part of your responsibilities. You will also manage project-specific vendors, assisting with Vendor Management Plans, providing training, tracking issues, and overseeing invoicing and payments.
• • You will manage the preparation, distribution, and reconciliation of study materials, including Operations Manuals and Investigator Site Files. Initiating and managing the production of various study plans and reports, collecting team input, and finalizing content with Project Manager oversight is also expected.
• • Collecting data and maintaining monthly Key Performance Indicators (KPIs) and project health data, circulating this information, and proactively identifying areas of concern for escalation are critical for project oversight. You will also manage the collection of functional team input for quarterly inspection readiness reviews and present findings.
• • You will be responsible for the training and onboarding of new PSS personnel, supporting the Project Manager in creating and maintaining sponsor-facing study storyboards, and tracking out-of-scope work, preparing materials for change order submissions.
• • You will support the development of processes, procedures, and work instructions for the PSS team and may act as a project manager for consulting agreements and standalone arrangements, escalating issues as needed.