Parexel
Parexel
Parexel ir globāla klīnisko pētījumu organizācija, kas apkalpo biofarmācijas uzņēmumus visā jaunu zāļu izstrādes procesā. Tās darbība aptver I–IV fāzes klīniskos pētījumus, portfeļa un pētījumu pārvaldību, regulatīvo stratēģiju, piekļuvi tirgum un zāļu dzīves cikla plānošanu. Ar vairāk nekā 21 000 profesionāļu Parexel apvieno klīnisko, regulatīvo un terapeitisko jomu zināšanas ar pacientu ieskatiem un inovatīviem pētījumu plāniem. Uzņēmums atbalsta pētniecību tādās jomās kā onkoloģija, neirozinātne un retās slimības, koncentrējoties uz efektīvāku un pacientcentrētāku klīnisko izstrādi.

Senior Clinical Trial Associate – Poland (Remote)

Support global clinical study teams at Parexel across trial operations, documentation, submissions, supplies, meetings, and Trial Master File maintenance. Coordinate study information and communications across affiliates, vendors, and internal stakeholders.

Apraksts

  • Provide logistical support to global study management teams throughout clinical study delivery
  • Build and maintain working relationships with study teams, affiliates, and vendors
  • Support the Clinical Trial Manager with communications between study teams and affiliates
  • Coordinate global study supplies through designated systems
  • Organize study meetings and prepare presentation materials
  • Consolidate study data for trackers and databases
  • Assist with protocol feasibility, country selection, and site selection activities
  • Support technical and logistical study operations
  • Maintain study documentation and report progress
  • Keep study management data, contact records, country contacts, and distribution lists current
  • Track Health Authority, IRB, and IEC submissions and approvals in CTMS, escalating delays and issues
  • Provide submission and supplementary materials to affiliates or Product Development Regulatory
  • Maintain study-level Trial Master File completeness under Clinical Trial Manager direction
  • Contribute to best practices and process improvements
  • Apply insights and recommendations from study debriefs and established best practices

Prasības

  • At least three years of global clinical-trial experience as a project specialist
  • Proficiency with CTMS, EDMS, Excel, Word, and related computer tools
  • Working knowledge of ICH-GCP Guidelines, international and local regulations, Parexel procedures, and client-specific procedures
  • Strong written and verbal communication skills
  • Ability to manage competing priorities and meet project timelines
  • Effective problem-solving capabilities
  • Ability to mentor and train less experienced colleagues when appropriate
  • Ability to serve actively as a process or platform Subject Matter Expert with minimal line-manager oversight
  • Fluency in written and spoken English and Polish
  • Relevant qualification or equivalent professional experience
  • High school diploma required; a life-science or related degree is preferred

Priekšrocības

  • Premium salary
  • Attractive benefits package
  • Medical care plan covering health, dental, and vision
  • Life assurance
  • Positive work environment
  • Team-oriented and collaborative culture
  • Access to innovative technology
  • Comprehensive training
  • Annual performance-based bonus plan for eligible roles
  • Annual salary review for eligible roles
  • Total rewards incentives for eligible roles

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