Associate Project Manager

hace 3 semanas

Bilbao, Vizcaya, España Pharmiweb A tiempo completo
Associate Project Manager

We are seeking a highly skilled Associate Project Manager to join our team in a permanent, fully home-based role. The successful candidate will be located in Bulgaria, Poland, Spain, or the UK.

Key Responsibilities:
  • Prepare and contribute to the preparation of delegated study documents, including Informed Consent Forms and Clinical Study Agreements.
  • Maintain and facilitate interactions with internal and external functions, including CROs and other external service providers, to ensure efficient study delivery.
  • Contribute to the planning and conduct of internal and external meetings, including Investigators' and Monitors' meetings.
  • Ensure the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers.
  • Proactively identify and mitigate risks and issues, and develop action plans as needed.
  • Verify the completeness and quality of study documents in the Trial Master File.
  • Support Global Study Directors and/or GSAD with budget management, including external service provider invoice reconciliation.
  • Adhere to global clinical processes, procedural documents, and international guidelines, such as ICH/GCP, to ensure study inspection readiness.
  • Support Global Study Directors and/or GSAD with overall project management, as per agreed delegation.
  • For outsourced studies, support Global Study Directors and/or GSAD in managing the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards.
Requirements:
  • University degree (or equivalent) in medical or biological sciences or a 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 and drug development processes 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 and work independently.
  • Demonstrated leadership skills.
  • Computer proficiency, advanced.

Location: Bulgaria, Poland, Spain, or the UK. Background: Clinical Research. Experience: At least 3 years in the pharmaceutical industry or similar organization, or academic experience.

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