Manager, Project Support Specialist

Position Summary :

The Manager, Project Support Specialist (PSS) is a dual-capacity role combining functional leadership with hands-on, Principal-level project delivery. This position provides direct line management to the Project Support team while simultaneously operating as a senior project team member on complex studies and portfolios. The role is accountable for building and leading a high-performing PSS function, driving consistent standards, scalable processes, and operational excellence. In parallel, the incumbent contributes directly to study execution, partnering with Project Management to ensure timely, high-quality delivery across programs.

Essential functions of the job include but are not limited to:

• Develop, mentor, manage and coach PSS staff to progress their skills to maintain Precision quality standards.
• Advocate individual career development, and individual responsibility/accountability.
• Ensure personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements.
• Participate in the interview process for new PSS staff by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Develop robust and flexible operational methodologies, standards and processes for the PSS role and ensure consistent, quality execution among the PSS personnel.
• Ensure that personnel have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Develop training plans and hold personnel accountable to achieving training goals or addressing training needs.
• Manage workload of supervised staff with continued assessment and adjustment as needed.
• Provide on-going feedback, development and coaching of CSSs including annual performance reviews.
• Mentor and train personnel in clinical study monitoring and the relevant applicable regulations, ICH- GCP Guidelines; ensures standards for monitoring and reporting are met.
• Manages and oversees the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team and sponsor input, and filing meeting agendas and minutes in the Trial Master File.
• Creates and maintains the project timeline in the appropriate system or tool. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team and sponsor. Identifies at risk activities and escalates to the PM and Functional Leads.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope.
• Manages and oversees study-specific training lifecycle by collecting, tracking, and loading training materials, assigning team members to appropriate training, and documenting completion of study-specific training in appropriate systems. Manages the maintenance of training records and files records in the Trial Master File.
• Proactively identifies gaps in training by reviewing team member training compliance on a defined periodic basis, and engages appropriate team members, Functional Leads, and/or line managers to ensure training completion.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors, and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages and oversees user access to study systems. Submits user access requests, reviews team member access to each system on a define periodic basis, and documenting access review. Ensure rapid removal of system access for team members no longer affiliated with the study.
• Orders study supplies and addresses queries on study supplies.
• Prepares study binder materials and works with vendor to ensure proper binder creation and shipping to study sites. Works with vendor to obtain project-related cost estimates. Ensures vendor quotes align with invoices for completed binders. Reviews and approves vendor-submitted invoices.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages and oversees the addition and removal of project team members in the finance system, including assignment of team members to specific tasks for time tracking.
• Reviews and approves weekly time reporting by team members. Works with study team members when issues are identified and escalates time reporting concerns to the Project Manager when necessary.
• With oversight of the Safety Lead, distributes and tracks IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Oversees the translation of site level documents, as applicable, per local and regional standards through document collection, tracking, vendor collaboration, engagement of stakeholders to evaluate translation completeness and vendor payments.
• Oversees project-specific vendors by assisting with development of the Vendor Management Plan, providing vendors with project trainings and access to systems, tracking vend...