Project Support Specialist II
P
Precision Medicine GroupClinical research
Remote, Brazil; Remote, MexicoFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English proficiently (Professional level).
- Experience
- Minimum 2 years relevant experience or demonstrated competencies in the key requirements of the role.
- Required Skills
- SharePointMicrosoft Office
Requirements
- Hold a four-year college degree or international equivalent, or have equivalent experience, ideally in a business, scientific, or healthcare discipline.
- Have a minimum of 2 years of relevant experience or demonstrated competencies in the key requirements of the role.
- Demonstrate fluency in Microsoft Office, 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 in a team environment.
Responsibilities
- Manage study meeting scheduling, agendas, minutes, and filing in the Trial Master File.
- Maintain project timelines by collecting, documenting, and communicating updates from team members.
- Coordinate study-specific training, training records, system access reviews, and shared study workspaces.
- Order study supplies and coordinate study binders, vendor estimates, invoices, and payments.
- Maintain study trackers and manage project team assignments and weekly time-reporting reviews.
- 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 management.
- Prepare, distribute, and reconcile study materials, and support the Project Manager with study plans, reports, and updates.
- Collect monthly KPIs and project health data, and gather input for quarterly inspection-readiness reviews.
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