Project Support Specialist

3 hours, 23 minutes ago
Full-time
Junior
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Manage the meeting lifecycle, including scheduling, agendas, minutes, updates, and filing records in the Trial Master File.
  • Assist with creating and maintaining project timelines in MS Project or a similar system and communicate status updates to the study team.
  • Perform study-related tasks in clinical systems based on role and project scope.
  • Manage study-specific training materials, assignments, completion tracking, and training records.
  • Monitor training compliance, identify gaps, and escalate issues to the Project Manager as needed.
  • Set up and maintain study-level shared workspaces and project-specific email boxes with appropriate access.
  • Manage user access to study systems, including requests, periodic reviews, documentation, and removal of access when needed.
  • Order study supplies and help resolve study supply questions.
  • Prepare study binder materials and coordinate with vendors for binder creation, shipping, quotes, and invoice reconciliation.
  • Maintain study trackers, finance system updates, weekly time reporting, KPIs, project health data, and inspection readiness inputs.
  • Support the Project Manager with study plans, reports, updates, storyboards, change-order materials, and out-of-scope tracking.
  • Coordinate project-specific vendors, including training, access, issue tracking, invoicing, and payment support.
  • Support distribution and tracking of safety reports such as IND Safety Reports, SUSARs, and CIOMS under oversight from the Safety Lead.
  • Manage translation of site-level documents and support reconciliation of study materials during applicable study phases.

Requirements

  • 4-year college degree or international equivalent, or equivalent experience in a business, scientific, or healthcare discipline.
  • Minimum 2 years of relevant experience or demonstrated competency in the role's key requirements.
  • Fluency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Strong customer service demeanor with flexibility, teamwork, and keen attention to detail.
  • Ability to communicate proficiently in English, both verbally and in writing.
  • Experience working with clinical systems, project trackers, or document management tools is preferred.
  • Experience with MS Project or a similar scheduling system is preferred.
  • Experience in clinical research, CRO operations, or study support is preferred.
  • Ability to manage multiple tasks across several studies with independent judgment and critical thinking.
  • Familiarity with Trial Master File processes, vendor coordination, or training compliance is preferred.

Benefits

  • Work supporting groundbreaking cancer therapies in oncology and rare disease programs.
  • Opportunity to contribute ideas and have your input valued.
  • A growing organization with room to make a positive impact.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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