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 meeting records within the Trial Master File.

• Assist in the development and upkeep of project timelines using MS Project or comparable systems.

• Execute activities and tasks within clinical systems relevant to the role and project scope.

• Manage study-specific training materials, track assignments and completions, and maintain records.

• Identify training deficiencies and escalate issues to the Project Manager.

• Set up and maintain study-level SharePoint sites or similar collaborative workspaces.

• Create and manage project-specific email accounts and control access.

• Oversee user access to study systems and conduct document access reviews.

• Order study supplies and respond to related inquiries.

• Prepare materials for study binders, coordinate vendor creation and shipping, and assist with vendor estimates, invoices, and payments.

• Maintain study trackers and manage project team members within the finance and time-tracking system.

• Review and approve weekly time reporting, addressing any concerns that arise.

• Support the distribution and monitoring of IND Safety Reports, SUSARs, and CIOMS.

• Manage the translation of site-level documents while coordinating with vendors, stakeholders, and handling payments.

• Assist with project-specific vendor management, including training, system access, issue resolution, invoicing, and payments.

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

• Provide support to the Project Manager with study plans, reports, updates, inspection readiness, KPIs, project health data, sponsor-facing storyboards, and change orders.

• Carry out other responsibilities as assigned by the Project Manager.

⛳️ Requirements

• A 4-year college degree or its international equivalent; or equivalent experience, preferably in a business, scientific, or healthcare field.

• At least 2 years of relevant experience or demonstrated competencies in the essential functions of the role.

• Proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• A customer service-oriented attitude, exhibiting flexibility, teamwork, and a strong attention to detail.

• Capability to communicate fluently in both spoken and written English (Professional level).

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

• Excellent interpersonal skills.

• High self-motivation and attention to detail; ability to work independently as well as collaboratively in a team setting.

• Strong written and verbal communication abilities.

• Candidates must be legally authorized to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodations are available for applicants with disabilities.

• Privacy protections are in place for application data.