Project Support Specialist II
P
Precision Medicine GroupClinical research
Location: Remote, Brazil; Remote, MexicoFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Ability to communicate both verbally and in writing at the English proficiently (Professional level).
- Experience
- Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.
- Required Skills
- Microsoft ExcelMicrosoft OfficePowerPoint
Requirements
- Have a 4-year college degree or international equivalent, or equivalent experience, ideally in a business, scientific, or healthcare discipline.
- Have at least 2 years of relevant experience or demonstrated competencies in the key requirements of the role.
- Be fluent in Microsoft Office programs, including Outlook, Word, Excel, and PowerPoint.
- Communicate verbally and in writing in English at a professional level.
- Have working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
- Demonstrate attention to detail, flexibility, teamwork, and a customer-service demeanor.
- Be able to plan and work independently and collaboratively.
Responsibilities
- Schedule internal and external meetings, prepare and circulate agendas, maintain meeting minutes, and file records in the Trial Master File.
- Assist with the project timeline in MS Project or a similar system by collecting, documenting, and communicating team updates.
- Manage study-specific training records, identify compliance gaps, and escalate issues to the Project Manager as needed.
- Establish study-level shared workspaces and email boxes, and manage team access to study systems.
- Order study supplies and coordinate study binder creation, shipping, vendor estimates, quotes, and payments.
- Maintain study trackers and manage project team assignments and weekly time reporting in the finance system.
- Support distribution and tracking of IND Safety Reports, SUSARs, and CIOMS, with oversight from the Safety Lead.
- Coordinate translation of site-level documents and support project-specific vendor training, issue tracking, invoicing, and payments.
- Prepare and reconcile study materials, and support the Project Manager with study plans, reports, KPIs, inspection readiness, sponsor-facing materials, and change orders.
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