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Clinical Project Specialist (Hybrid)

ProPharma · Skopje

Nouveau
Hybrid Mid 🇬🇧 English
EDC CTMS IVRS eTMF ICH/GCP

Description du poste

About the role

ProPharma, a consultancy supporting biotech, medical device and pharmaceutical organisations across the full product lifecycle, is looking for an experienced Clinical Project Specialist to join its team in Serbia, Croatia, North Macedonia or Bosnia and Herzegovina. The role provides general administrative project management support for assigned projects and covers administrative tasks supporting clinical trial execution. It is a hybrid position with three days a week in one of the offices.

Key responsibilities

  • Assist with developing and formatting documents, reviewing and reconciling study-specific information.
  • Support the day-to-day operations of clinical study execution in line with SOPs, ICH/GCP guidelines and other regulatory requirements.
  • Help collect, disseminate, track and file documents according to organisational processes and regulations.
  • Assist with preparing and distributing site binders as requested.
  • Track and prepare study-specific information using databases, spreadsheets and other tools as assigned.
  • Work closely with study team members and the study manager on study execution tasks.
  • Take part in process improvement and quality-related initiatives linked to study execution and departmental deliverables.

Required profile

  • Over 2 years of experience in a pharmaceutical or clinical research environment in a similar clinical role.
  • Previous experience taking minutes and providing basic administrative project support.

Required skills

  • Experience with electronic data capture (EDC), CTMS, IVRS and eTMF.

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ProPharma

Skopje