Project Support Specialist II (LATAM)

Precision Medicine Group; México; Remoto; MXN 420.000 - 540.000; Tempo pieno

Descrizione del lavoro

Precision Medicine Group in Mexico is expanding its project operations and seeks a Project Support Specialist II to join our growing team. The role provides cross-functional support, helps manage timelines, training, and document control across multiple studies with guidance as needed.

The ideal candidate will coordinate meetings, track KPIs, support vendor management, and assist with project plans and reports under supervision. Fluent English and strong organizational skills are essential.

Competenze

• 4-year college degree or international equivalent; or equivalent experience in business, science, or healthcare.
• Minimum 2 years of relevant experience in project support or coordination.
• Fluency in Microsoft Office; strong written and verbal English communication.
• Working knowledge of ICH-GCP, SOPs, and regulatory guidance.

Mansioni

• Manages the meeting lifecycle: scheduling, agendas, minutes, and filing in the Trial Master File.
• Maintains project timelines in MS Project or similar system and shares updates with the team.
• Performs activities in clinical systems relevant to the role and project scope.
• Manages training lifecycle and maintains study training materials and records.
• Identifies training gaps and escalates to the Project Manager as needed.
• Creates study-level SharePoint site and manages access for team and sponsors.
• Manages user access to study systems and performs periodic access reviews.
• Coordinates study supplies, binders, and vendor communications for costs and invoices.
• Maintains trackers and supports KPI collection and project health reporting.
• Supports vendor management plans, training, and issue tracking.

Conoscenze

Project coordination

Cross-functional collaboration

Attention to detail

Time management

English proficiency

Formazione

4-year college degree or international equivalent

Strumenti

Microsoft Office

MS Project

Descrizione del lavoro

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 and maintenance of the Sponsor-facing study story board.
• Supports the Project Manager in tracking out of scope work. Prepares, with guidance, materials required for the submission of change orders.
• Performs other duties as assigned by the Project Manager.

Qualifications:

• 4-year college degree or international equivalent; or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level).
• Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Strong written and verbal communication skills

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