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Associate Project Management - Clinical Studies

TFS HealthScience · Stockholm

New
Mid 🇬🇧 English
CTMS TMF MS Office ICH-GCP

Job description

About the role

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. The Project Management Associate supports the Clinical Operations and Project Management teams by providing operational and project coordination support to global clinical trials. Working as part of a cross-functional study team, you will help ensure studies run efficiently, on time, within budget and in compliance with regulations, SOPs and sponsor requirements. You will be dedicated to one sponsor, a global pharmaceutical or biotechnology company.

Key responsibilities

  • Provide operational and administrative support to Project Managers and Clinical Research Managers throughout the clinical trial lifecycle.
  • Maintain and update study information in CTMS and other study systems to ensure data accuracy and compliance.
  • Coordinate study documentation, meeting logistics, action trackers, communication plans and project records.
  • Support vendor oversight, investigator payments, financial tracking and study budget reconciliation.
  • Prepare study reports, presentations, meeting agendas and minutes, and track project deliverables and timelines.
  • Act as central contact for study communications across internal teams, sites, vendors and sponsors.
  • Assist with regulatory submissions, amendments, audits, inspections and document management.
  • Contribute to Trial Master File (TMF) and Investigator Site File (ISF) maintenance.
  • Support study supply coordination and logistics, and collaborate with global cross-functional teams.

Required profile

  • Bachelor's degree in Life Sciences, Healthcare, Pharmacy or a related field, or equivalent relevant experience.
  • Previous experience in clinical research, clinical operations, project coordination or study management.
  • Understanding of ICH-GCP guidelines and the clinical trial process.
  • Strong organisational skills and excellent written and verbal English.
  • Experience supporting global clinical studies is an advantage.

Required skills

  • Proficiency with MS Office applications.
  • Proficiency with clinical trial systems such as CTMS, TMF or similar platforms.

Questions fréquentes

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Source : ats:teamtailor

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Published för 3 dagar sedan

Expires om 1 månad

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TFS HealthScience

Stockholm