Project Support Specialist II

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

• Oversee the entire meeting lifecycle, which includes scheduling meetings, preparing agendas, documenting and updating minutes, and organizing records within the Trial Master File.

• Assist in developing and sustaining project timelines using MS Project or equivalent tools.

• Execute activities and tasks within clinical systems.

• Manage the development of study-specific training materials, oversee assignments, track completion, and maintain records.

• Create SharePoint sites for studies and manage user access.

• Set up project-specific email accounts and ensure access management.

• Control user access to study systems and perform regular access reviews.

• Procure study supplies and respond to related inquiries.

• Compile study binder materials and coordinate with vendors for creation, shipping, estimates, invoices, and payments.

• Maintain study trackers and oversee project team members in finance and time-tracking systems.

• Review and monitor weekly time reporting and escalate any issues as necessary.

• Assist in the distribution and tracking of IND Safety Reports, SUSARs, and CIOMS.

• Manage the translation of site-level documents and coordinate with vendors and stakeholders.

• Support vendor management specific to projects, including training, access, issue resolution, invoicing, and payments.

• Oversee the preparation, distribution, and reconciliation of study materials.

• Assist the Project Manager with study plans, reports, updates, sponsor-facing storyboards, and change orders.

• Gather and maintain monthly KPIs, project health metrics, and quarterly inputs for inspection readiness.

• Carry out additional tasks as directed by the Project Manager.

⛳️ Requirements

• A bachelor's degree or international equivalent; or relevant experience preferably in a business, scientific, or healthcare field.

• At least 2 years of relevant experience or proven skills in the key responsibilities of this role.

• Proficiency in Microsoft Office applications: Outlook, Word, Excel, and PowerPoint.

• Strong verbal and written communication skills in English at a professional level.

• Familiarity with ICH-GCP, Precision SOPs, and regulatory guidelines.

• Ability to work independently and plan effectively, as well as collaborate within a team environment.

• Candidates must have legal authorization to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Flexible remote work options available in Brazil or Mexico.

• Commitment to being an Equal Opportunity Employer.

• Provision of reasonable accommodations during the application process.