Senior Project Coordinator

hace 4 semanas

Madrid, Madrid, España Icon A tiempo completo

We are seeking a highly skilled Senior Project Coordinator to join our team at ICON. The successful candidate will be responsible for leading the preparation of delegated study documents and external service provider related documents.

Key Responsibilities:

  • Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement, etc.) and external service provider related documents (specifications, study specific procedures, descriptions, presentations, etc.).
  • Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure efficient study delivery to time, costs, and quality objectives.
  • Contributes to the planning and conduct of internal and external meetings (e.g., Investigators'/Monitors' meeting).
  • Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
  • Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
  • Ensures that all study documents in scope of global associate project manager responsibilities are complete and verified for quality in the Trial Master File.
  • Supports Global Study Directors and/or GSAD with budget management, such as external service provider invoice reconciliation.
  • Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines such as ICH/GCP to ensure the study is inspection ready at all times.
  • For outsourced studies, supports Global Study Directors and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study.

Minimum Requirements:

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
  • Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
  • Vendor management experience.
  • Knowledge of clinical development/drug development process in various phases of development and therapy areas.
  • Excellent knowledge of international guidelines ICH/GCP.
  • Excellent communication and relationship building skills, including external service provider management skills.
  • Good project management skills.
  • Demonstrated ability to collaborate as well as work independently.
  • Demonstrated leadership skills.
  • Computer proficiency, advanced

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