Full-time

Parexel is hiring a Project Specialist I

About the Role

At Parexel, we all share the same goal - to improve the world's health. We take our work personally, we do it with empathy, and we're committed to making a difference. We are looking for a Project Specialist I to support project management activities across the entire project lifecycle, from initiation to closure. You will play a key role in maintaining project systems, generating reports and metrics, reviewing financials, and coordinating with project leaders and functional leads to ensure project deliverables are met.

What You'll Do

  • Set up and maintain Project Management Plans with Project Leader input.
  • Maintain selected information in the integrated project management system and work with other functions on data compliance.
  • Generate project reports, compliance and other metrics for project operational review, client and internal reporting.
  • Review selected financial areas and follow up with stakeholders on required corrections.
  • Cooperate with the Project Leader and Functional Leads on action plans and follow up with the project team until completion.
  • Provide oversight of the project team list, project system accesses, and respective reviews.
  • Update and customize systems, tools, and project plans according to applicable SOPs.
  • Support vendor selection and create the Project-specific training curriculum.
  • Review time booking and analyze overconsumption with Functional Lead input.
  • Review pass-through costs and vendor invoices.
  • Cooperate with TMF lead, IPO and eCBL on set up and manage project close-out activities.
  • Work with Project Leader and Functional Leads to ensure project resources are requested in line with project scope.
  • Collect, distribute, and track insurances and Letters of Authorization.
  • Perform study reporting and analysis, highlighting issues for the project team.
  • Maintain consistent, coherent project management plans, including communication and coordinated planning.
  • Review Project Specific Training Compliance and follow up on non-compliances.
  • Assist with preparation, conduct, and action follow-up for Project Operational review meetings.
  • Provide reports, metrics, and analysis for informed Project Leader decision making.
  • If delegated, provide oversight on defined project management areas on behalf of the Project Leader.
  • Prepare for and attend project meetings, supporting the preparation of required information.
  • Collaborate to ensure study supplies are delivered as required and according to contract obligations.
  • Utilize the close-out checklist to drive timely operational project close-out.
  • Collaborate with the Project Leader on ensuring systems are closed, documents are archived, and final work is handed over.
  • Support preparation of the financial close out.
  • If assigned as SME/Mentor, train and mentor new starters in systems and tools.
  • Provide feedback to PS/PL Super User in CRS technology to enhance tools and processes.

What We're Looking For

  • Minimum of one year experience in the Project Specialist role, or more than 2 years’ experience in Clinical Research.
  • A good understanding of how your role integrates with others to accomplish project deliverables and objectives.
  • Experience working globally across regions.
  • Knowledge of ICH / GCP guidelines.
  • Intermediate to Advanced English level for non-native English speakers.
  • A minimum bachelor’s degree or equivalent.

Team & Environment

This role works in a matrix environment, collaborating closely with the Project Leader and various Functional Leads.

Required Skills
Project ManagementClinical ResearchRegulatory SubmissionsCommunicationDocumentationMicrosoft OfficeProblem SolvingTime ManagementCross-functional CollaborationDetail-Oriented
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About company
Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

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Job Details
Category other
Posted 5 months ago