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Parexel

Senior Clinical Study Administrator – FSP

Parexel

. Coordinate and administer clinical studies from start-up through execution and closeout .

Posted 11/3/2026full-timeWarsaw • PolandSenior💰 PLN 100,000 - PLN 130,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in coordinating clinical studies, ensuring compliance with ICH-GCP guidelines, and maintaining essential documentation for inspection readiness. Proficient in managing administrative tasks and communication tools to support study execution and collaboration with diverse stakeholders.

Highest-signal resume keywords
Clinical Study CoordinationICH-GCP ComplianceDocument ManagementCommunication SkillsOrganizational Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Study ProcessDocument PreparationData ManagementElectronic Trial Master File (eTMF)Client Tracking ToolsRegulatory SubmissionsTemplate ComplianceLanguage ControlContract PreparationHCO and HCP Payments
Soft Skills
Attention to DetailTime ManagementInterpersonal SkillsTeam CollaborationFlexibility
Tools & Technologies
CTMSVCVSharePointANGELGlobal Electronic Management Systems
Industry Keywords
Clinical TrialsLife SciencesMedical AdministrationRegulatory AuthoritiesEthics Committees

About the role

Key responsibilities & impact
  • Coordinate and administer clinical studies from start-up through execution and closeout
  • Serve as the local administrative main contact, working with CRAs and the Local Study Associate Director
  • Set up, populate, and maintain client tracking and communication tools such as CTMS, VCV, and SharePoint
  • Coordinate and track study materials and equipment
  • Coordinate administrative tasks during study processes, audits, and regulatory inspections
  • Lead practical arrangements for internal and external meetings and contribute to meeting preparation
  • Liaise with internal and external participants, vendors, investigators, service providers, and CRAs
  • Prepare and distribute presentation materials, newsletters, websites, letters, and meeting minutes
  • Maintain the local electronic Trial Master File (eTMF) and Investigator Site File (ISF)
  • Track and upload essential documents to maintain eTMF inspection readiness
  • Prepare documents for final archiving and support ISF close-out activities
  • Contribute to study document production and maintenance, including template and version compliance
  • Handle layout and language control, copying, distribution, local translation, and English spell checks
  • Facilitate delivery of study-related documents and materials with Data Management and Global Clinical Solutions representatives
  • Collect, prepare, review, and track documents for applications and submissions
  • Submit applications and documents to ethics committees, institutional review boards, and regulatory authorities
  • Create or import clinical-regulatory documents into global electronic management systems such as ANGEL
  • Support electronic applications and submissions to Submission Ready Standards
  • Prepare or support site-level contract preparation
  • Prepare, support, or perform HCO and HCP payments in accordance with local regulations
  • Ensure compliance with client ethics, company policies, legislation, ICH-GCP, and other applicable requirements
  • Complete required training, timesheets, expense reports, and CV updates

Requirements

What you’ll need
  • Excellent organization and time management skills
  • Excellent attention to detail
  • Good verbal and written communication skills
  • Good interpersonal skills and ability to work effectively in an international team environment
  • Willingness and ability to train others on study administration procedures
  • Ability to multi-task in a high-volume environment with shifting priorities
  • Team-oriented and flexible approach, with ability to respond quickly to shifting demands and opportunities
  • Integrity and high ethical standards
  • Ability to develop advanced computer skills to increase efficiency in daily tasks
  • Proven organizational and administrative skills
  • Computer proficiency
  • Proficient in written and spoken English
  • Fluency in local language(s)
  • Previous administrative experience, preferably in the medical or life science field
  • High school or secondary school qualifications (or an equivalent adapted to local market needs)
  • Working knowledge of the clinical study process and related working procedures (preferred)
  • Understanding of ICH-GCP guidelines (preferred)
  • Further studies in administration and/or life science (preferred)

Benefits

Comp & perks
  • Premium salary
  • Attractive benefits
  • Car or car allowance
  • Medical care plan: Health, Dental & Vision
  • Life Assurance
  • Excellent work environment
  • Culture of teamwork and collaboration
  • People who motivate and face challenges together
  • Innovative technology
  • Excellent training
  • Paid time off
  • Life insurance
  • Health insurance
  • Additional benefit offerings in accordance with the terms of applicable plans
  • Some roles may be eligible for additional incentives, bonuses, or other compensation programs