Country Study Specialist (CSS)

Roche

  • Madrid
  • Permanente
  • Tiempo completo
  • Hace 1 mes
The Country Study Specialist (CSS) is responsible for providing operational/tactical support to Country Study Managers (CSMs) from study start-up through study conduct, database lock and close-out activities.

Provides support to CSMs:
  • On operational/tactical aspects for implementation of clinical trial activities from study start-up through database lock, contributing to ensure Roche quality and safety standards, regulations, timelines and budget commitments.
  • Works with CSMs to support them with the day-to-day activities of the study, including start-up activities prior to site activation, conduct and close-out activities, proactively contributing to support efficient studies.
  • Maintains effective and ongoing communication with CSMs and provides them with regular status and activity reports, escalating study issues/concerns.
  • Supports communication to sites to contribute to the clinical studies delivery.
  • Provides tactical/operational support to Contract Research Organization (CRO) in those areas identified to support the CSM’s strategic oversight.
  • Ensures appropriate tracking systems and tools are in place to ensure compliance with regulations, internal policies, ICH-GCP, etc.
  • Supports CSMs for audits/inspections activities.
  • Identifies opportunities for efficiencies and shares best practices within CCO.
Provides support to CSMs: * On operational/tactical aspects for implementation of clinical trial activities from study start-up through database lock, contributing to ensure Roche quality and safety standards, regulations, timelines and budget commitments.
  • Works with CSMs to support them with the day-to-day activities of the study, including start-up activities prior to site activation, conduct and close-out activities, proactively contributing to support efficient studies.
  • Maintains effective and ongoing communication with CSMs and provides them with regular status and activity reports, escalating study issues/concerns.
  • Supports communication to sites to contribute to the clinical studies delivery.
  • Provides tactical/operational support to Contract Research Organization (CRO) in those areas identified to support the CSM’s strategic oversight.
  • Ensures appropriate tracking systems and tools are in place to ensure compliance with regulations, internal policies, ICH-GCP, etc.
  • Supports CSMs for audits/inspections activities.
  • Identifies opportunities for efficiencies and shares best practices within CCO.
Requirements:
  • University Degree in a medical/science-related field.
  • Postgraduate education: Master's Degree or Specialization in Clinical Development.
  • Demonstrated knowledge of clinical studies with at least 4-year experience in managing projects as a Clinical Trial Monitor.
  • Demonstrated knowledge of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice (ICH-GCP), as well as the regulatory, ethics and contractual requirements for starting clinical trials in Spain.
  • Demonstrated ability to interact with different stakeholders in the clinical development arena.
  • Experience on influencing and negotiating at all levels to achieve team delivery.
  • High English level.
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
  • Availability to travel.
Competencies profile:
  • Technical/Professional Knowledge & Skills
  • Adaptability in an hybrid/combining role
  • Decision Making
  • Influencing
  • Building Partnerships
  • Communication
  • Building Customer Loyalty
  • Innovation
Roche is an equal opportunity employer. Research & Development, Research & Development
Clinical Operations

Roche

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