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Senior Clinical Research Associate – Sponsor Dedicated (Denmark)

syneoshealth · DNK-Client

New
Senior 🇬🇧 English
Good Clinical Practice ICH-GCP Source document review

Job description

About the role

Syneos Health is seeking a Senior Clinical Research Associate (Sponsor dedicated) to support real‑world late‑phase studies in Denmark. The role involves comprehensive site management from qualification through close‑out, ensuring compliance with regulatory and protocol requirements.

Key responsibilities

  • Perform site qualification, initiation, monitoring, management and close‑out visits, both on‑site and remotely.
  • Review informed consent processes, source documents, and case report forms for accuracy and completeness.
  • Manage investigational product inventory, reconciliation, and compliance with labeling and storage requirements.
  • Document activities through trip reports, letters, and logs, and support recruitment and retention strategies.
  • Collaborate with project teams, act as liaison with site personnel, and contribute to audit readiness.

Required profile

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Strong knowledge of ICH‑GCP, Good Pharmacoepidemiology Practice and applicable regulatory guidelines.
  • Excellent communication, presentation and interpersonal skills.
  • Ability to travel up to 75% of the time.

Required skills

  • Good Clinical Practice (GCP) and ICH guideline expertise.
  • Site monitoring and management experience.
  • Investigational product handling and reconciliation.
  • Source document review and data verification.

Questions fréquentes

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Source : ats:workday

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Published for 12 timer siden

Expires om 1 måned

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syneoshealth

DNK-Client