Manager, Project Support Specialist

Role Overview

• 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 vendor issues and overseeing vendor invoicing and payments.
• Manages and oversees the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Initiates and manages the production of various study plans, reports, and updates (e.g., PM plan, country/site initiation, activation, recruitment) including preparing initial drafts, managing the collection of team member input, and finalizing content with oversight by the Project Manager.
• Collects data and maintains monthly Key Performance Indicators (KPIs) and project health data. Circulates data to the Project Manager and internal team members as appropriate. Proactively identifies areas of concern for escalation to the Project Manager and/or Functional Leads
• Manages and oversees collection of functional team input for the quarterly inspection readiness review. Presents inspection readiness to the Project Manager and determines areas for Departmental escalations.
• Responsible for training and on-boarding of new PSS personnel.
• Supports the Project Manager in the creation and maintenance of the Sponsor-facing study story board. Proactively updates materials based on project progress.
• Tracks out of scope work and ensures Project Manager is aware and aligned with progression of proposed project scope changes. Prepares materials required for the submission of change orders.
• Supports development of processes, procedures, and work instructions for the PSS team.
• Acts as project manager for consulting agreements and standalone arrangements, responsible for most project manager activities on these projects and escalating to project management leadership when issues arise.

Requirements

• Bachelor’s degree or equivalent experience, ideally in a business, scientific or healthcare discipline.
• At least 8 years of clinical research experience as a PSS or equivalent relevant experience and or demonstrated competencies in the key requirements of the role.
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint).
• Strong communication and interpersonal skills to effectively interface with others in a team setting.
• Strong organizational skills, attention to detail, and a customer service demeanor.
• Ability to undertake occasional travel domestically and internationally including overnight stays.
• Ability to communicate verbally and in writing in English (Professional level).
• Prior line management experience.
• Project support experience.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Paid time off
• Professional development opportunities