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Senior Clinical Trial Manager (Home Based, Spain)

syneoshealth · ESP-Remote (Madrid)

Nuevo Remote
Remote Senior 🇬🇧 English
ICH Guidelines Risk-based monitoring

Descripcion del puesto

About the role

Syneos Health is hiring a Senior Clinical Trial Manager (Sr CTM) who works remotely from Spain. The role manages global or multi-country studies and requires proven vendor management experience. It is a home-based position within the Clinical Solutions team.

Key responsibilities

  • Support protocol development, including the Clinical Study Blueprint, protocol, amendments and administrative changes
  • Manage study budgets, site contract negotiations and amendments, and oversee site and vendor payments
  • Assist with site selection, feasibility questionnaires, green light letters and site contracts
  • Review the data management plan, prepare interim and final database locks, and manage study timelines and the study team
  • Support study-specific training, investigator meetings and the trial master file (TMF)
  • Oversee vendors, including vendor oversight plans, contracts and work orders
  • Help set up review committees, develop site closure and patient recruitment strategies, and run risk assessments and issue management
  • Build the study-specific informed consent form, support CTA submissions, keep the CTMS updated and attend study and vendor meetings

Required profile

  • Bachelor's degree or RN in a related field, or equivalent education, training and experience
  • 5+ years as a CTM managing multiple countries for regional or global trials
  • Proven vendor management and global study management experience
  • Experience in oncology clinical trials
  • Ability to lead teams, work internationally and moderate travel (about 20%)

Required skills

  • Good computer skills and knowledge of clinical trial management financial principles and budget management
  • Knowledge of GCP/ICH guidelines and applicable regulatory requirements
  • Preferred: risk-based monitoring experience

Questions fréquentes

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Source : ats:workday

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Publicado hace 4 horas

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syneoshealth

ESP-Remote (Madrid)