Associate Project Manager

hace 2 semanas

Madrid, Madrid, España Icon A tiempo completo
Job Title: Associate Project Manager

We are seeking a highly skilled and experienced Associate Project Manager to join our team at ICON. As a key member of our global study team, you will play a critical role in the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management.

Responsibilities:
  • Leads/contributes to the preparation of delegated study documents, including Informed Consent Forms, Clinical Study Agreements, and external service provider related documents.
  • Maintains and facilitates interactions with internal functions and external functions, including 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, including Investigators' and Monitors' meetings.
  • 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, including external service provider invoice reconciliation.
  • Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines, including 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.
Qualifications:
  • 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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