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Clinical Research Manager – Ophthalmology (Retina)

Safeguard Global

🇬🇧 English
ICH/GCP CTMS TMF

Descripcion del puesto

About the role

This position leads country‑ and site‑level delivery of retina clinical trials within a dedicated ophthalmology team. You will own end‑to‑end Clinical Research Management (CRM) for cutting‑edge studies, ensuring compliance with SOPs, ICH/GCP and regulatory standards.

Key responsibilities

  • Own clinical operations delivery against protocol, SOPs and regulatory standards.
  • Serve as the primary operational point of contact for sponsors.
  • Lead, train and supervise CRAs, including co‑monitoring and review of visit reports.
  • Drive site and country performance: monitoring oversight, protocol deviations, recruitment and issue escalation.
  • Maintain oversight of TMF quality, CTMS accuracy and study documentation.
  • Partner with the Project Manager on planning, investigator payments, resourcing and forecasting.
  • Contribute to investigator meetings, feasibility assessments and start‑up (“greenlight”) activities.

Required profile

  • Minimum 5 years of clinical monitoring experience in CRO, pharma or biotech.
  • At least 1 year as a CRM with independent oversight of site and country operations.
  • Direct ophthalmology trial experience, preferably in retina indications (DME, AMD, GA, RVO, IRDs).
  • Full‑lifecycle study exposure, including start‑up/activation.
  • Full English proficiency.

Required skills

  • ICH/GCP knowledge.
  • CTMS proficiency.
  • TMF management.

Questions fréquentes

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