Clinical Trial Operations Specialist

3 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

About the Role:

The Global Study Manager will be responsible for managing clinical studies from initiation to closure, ensuring timely delivery, within budget and to the required quality standards.

This role will involve working cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Global Study Associate Director (GSAD).

Main Responsibilities:

  • To provide oversight to ensure study delivery in partnership with AZ enablement team, other AZ clinical experts and external service providers.
  • To lead/contribute to the preparation of delegated study documents and external service provider related documents.
  • To maintain and facilitate interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including CROs and other external service providers.
  • To contribute to the planning and conduct of internal and external meetings.
  • To ensure the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
  • To proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
  • To ensure that all study documents in scope of GSM's responsibilities are complete and verified for quality in Trial Master File.
  • To support Global Study Associate Director (GSAD) with budget management, such as external service provider invoice reconciliation.
  • To adhere to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
  • To support GSAD in project management as per agreed delegation.
  • To take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

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


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