Project Support Specialist II (LATAM)

pfm; Brasil; Sur place; BRL 60 000 - 100 000; Plein temps

Résumé du poste

pfm is expanding across Latin America and is seeking a Project Support Specialist II to join our growing team. This role provides cross-functional support to studies, executing core responsibilities with oversight and applying independent judgment to drive study progress.

Essential duties include managing meeting lifecycles, updating project timelines, training records, SharePoint sites, user access, vendor coordination, and preparing study materials and plans with the Project Manager.

Qualifications

• Experience coordinating cross-functional teams in clinical studies.
• Familiarity with project management tools (e.g., MS Project).
• Ability to organize training lifecycles and track completion.

Responsabilités

• Manages the meeting lifecycle including scheduling, agendas, minutes, and filing in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system, collects updates and communicates them to the team.
• Performs tasks in clinical systems applicable to their role and project scope.
• Manages study-specific training lifecycle, tracks training, and documents completion in systems.
• Identifies training gaps and escalates to the Project Manager as needed.
• Establishes study-level SharePoint or similar space and manages access for team and sponsor.
• Creates project-specific email boxes and maintains access for team members.
• Manages user access to study systems and reviews access periodically.
• Orders study supplies and addresses queries on supplies.
• Prepares study binder materials and coordinates vendor quotes and payments.
• Maintains study trackers and supports project managers with data feeds.
• Manages addition/removal of team members in the finance system and time tracking assignments.
• Reviews and approves weekly time reporting and escalates concerns as needed.
• Supports translation of site-level documents as applicable and vendor payments.

Description du poste

We're expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we're looking for a Project Support Specialist to join our growing team!

The Project Support Specialist II (PSS II) serves as a member of the project team providing cross-functional support with the goal of making a positive impact on the studies to which they are assigned. The PSS II is a solid team member who can execute, with some oversight, all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS II effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

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

• Manages the meeting lifecycle including scheduling internal and external meetings, preparing, and circulating agendas, taking meeting minutes, circulating, and updating meeting minutes based on team member input, and filing meeting agendas and minutes in the Trial Master File.
• Assists with creation and maintenance of the project timeline in MS Project or similar system. Collects updates from team members, captures and documents these updates, and ensures updates are communicated to the cross-functional study team.
• Performs an array of activities and tasks in clinical systems applicable to their role and project scope..
• Manages 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.
• Identifies gaps in training by reviewing team member training compliance on a defined periodic basis and engages appropriate team members to ensure training completeness. Escalates to the Project Manager as needed.
• 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 user access to study systems by submitting user requests to the Helpdesk or similar, by reviewing team member access on a defined periodic basis, and documenting access reviews. 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 and consults directly with Project Manager to approve vendor payments.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager, or other project leader.
• Manages 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. Identifies and escalates time reporting concerns to the Project Manager.
• With oversight by the Safety Lead, supports the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable.
• Manages 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.
• Supports the management of 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 the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• Supports the Project Manager with 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.
• 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.
• Collects functional team input for the quarterly inspection readiness review.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Supports the Project Manager in the creation