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 knowledge, laboratory expertise, and advanced data sciences to accelerate the development of life-changing therapies for patients. We are at the forefront of Oncology and Rare Disease research, and we are seeking a dynamic and experienced Manager, Project Support Specialist to be based remotely in Taiwan.
• • This is a unique dual-capacity role, offering the opportunity to provide functional leadership as a Manager while also contributing hands-on as a Principal-level Project Support Specialist on complex clinical studies and portfolios. You will be instrumental in building and leading a high-performing Project Support Specialist (PSS) team, establishing consistent standards, scalable processes, and driving operational excellence across the function.
• • As a functional leader, your responsibilities will include developing, mentoring, managing, and coaching PSS staff to ensure they consistently meet Precision's high-quality standards. You will champion individual career development, foster a sense of responsibility and accountability within the team, and ensure all personnel adhere to established SOPs, working guidelines, project plans, and regulatory requirements.
• • You will play a key role in talent acquisition by participating in the interview process, conducting CV reviews, and contributing to the selection of new PSS team members. Furthermore, you will collaborate with Human Resources, Clinical Training, and other functional areas to develop and deliver comprehensive onboarding training for new hires, ensuring they are well-prepared for their roles.
• • A significant aspect of this role involves developing robust and flexible operational methodologies, standards, and processes specifically for the PSS function. You will be responsible for ensuring the consistent and high-quality execution of these processes by your team, providing them with the necessary resources, training, materials, and system access to excel.
• • You will conduct regular performance reviews, provide ongoing feedback, and offer development and coaching to your team members, including conducting annual performance appraisals. Mentoring and training personnel in clinical study monitoring, relevant applicable regulations, and ICH-GCP Guidelines will be crucial, ensuring that all monitoring and reporting standards are met.
• • In your hands-on project delivery capacity, you will manage and oversee the entire meeting lifecycle for complex studies. This includes scheduling internal and external meetings, preparing and circulating agendas, meticulously taking meeting minutes, circulating and updating minutes based on team and sponsor feedback, and ensuring all meeting documentation is correctly filed in the Trial Master File (TMF).
• • You will be responsible for creating and maintaining project timelines within appropriate systems, collecting updates from team members, documenting these updates, and ensuring clear communication to the cross-functional study team and sponsors. Proactively identifying at-risk activities and escalating them to the Project Manager and Functional Leads will be a critical part of your project oversight.
• • You will perform a wide array of activities and tasks within clinical systems, directly contributing to study execution based on project scope. This includes managing and overseeing the study-specific training lifecycle: collecting, tracking, and loading training materials, assigning training to team members, documenting completion in appropriate systems, and maintaining training records in the TMF.
• • You will proactively identify training gaps by regularly reviewing team member compliance and engaging with appropriate stakeholders to ensure timely completion. Establishing and managing study-level SharePoint sites or similar shared working spaces, ensuring appropriate access for study teams, sponsors, and other relevant parties, will be part of your responsibilities.
• • You will also manage project-specific email boxes and maintain appropriate access for study team members. Overseeing user access to study systems, submitting access requests, conducting periodic reviews of team member access, and ensuring prompt removal of access for departing team members are essential tasks.
• • Additional project support duties include ordering study supplies, addressing supply-related queries, preparing study binder materials, coordinating with vendors for binder creation and shipping, obtaining project-related cost estimates, reviewing and approving vendor invoices, and maintaining various study trackers as directed by project leadership.
• • You will manage the addition and removal of project team members in the finance system, ensuring accurate task assignment for time tracking, and reviewing/approving weekly time reports, escalating issues as necessary.
• • With oversight from the Safety Lead, you will distribute and track IND Safety Reports/SUSARS/CIOMS according to study-specific procedures. You will also oversee the translation of site-level documents, managing vendor collaboration, stakeholder engagement, and payment processes.
• • You will oversee study-specific vendors, assisting with Vendor Management Plans, providing training and system access, tracking issues, and managing invoicing and payments. This includes managing the preparation, distribution, and reconciliation of study materials like Operations Manuals and ISFs.
• • You will initiate and manage the production of various study plans and reports, collecting team input and finalizing content. You will also collect data and maintain monthly Key Performance Indicators (KPIs) and project health data, circulating this information and identifying areas for escalation.
• • Furthermore, you will manage the collection of functional team input for quarterly inspection readiness reviews and present findings to project management. You will support the Project Manager in creating and maintaining sponsor-facing study storyboards and track out-of-scope work, preparing materials for change order submissions.
• • You will contribute to 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 to leadership as needed.
• • This role is critical to ensuring the efficient and high-quality execution of our clinical trials, directly impacting our ability to bring life-changing therapies to patients faster.