Trial Master File (TMF) Governance Liaison Manager
Novartis
Bâle, Canton de Bâle-Ville, Switzerland
vor 17 Tg.

Description du poste : Description de poste Responsible for developing and ensuring implementation of TMF processes, systems and tools (including trainings) to improve TMF compliance across Novartis in accordance with International Pharma Regulations and Ethical requirements. Your responsibilities : 1.

Coordinate the development and implementation of new standards for TMF in order to ensure Novartis compliance with International Pharma Regulations and Ethical requirements. 2.

Translate trial information, processes and regulations into TMF documentation.

Key contributor to drive improvements and innovation on all business and technical aspects of TMF management and archiving, including implementation of innovative methods.

Support their implementation. 3.

Contribute to defining the document management strategy for the Clinical study documentation and oversee the process, systems and tools for implementation. 4.

Act as first line of governance between key groups internally (QA, QC Group, Submission, Clinical Trial Team) and externally (MHRA, auditors / inspectors).

Collaborate with key stakeholders including other groups from Document Management and Governance, Development Informatics, Development Quality Assurance, Clinical Submission, Early development, line functions representatives and Country Pharma Organizations. 5.

Promote best documentation practice to line functions to ensure that documents created / generated in the course of clinical research are managed and archived in accordance with GCP guidelines and Novartis SOPs 6.

Key contributor to drive TMF activities related to Pharma Quality Plan and HA / Audit CA-PAs.

Monitor the implementation of CAPAs related to TMF process, systems and tools and ensure that deliverables are met according to timelines.

Description du profil : Exigences minimales What you'll bring to the role :

  • Bachelor's degree required with minimum 5 years experience in clinical operations and / or clinical document management.
  • Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice.
  • Novartis experience in clinical development process is preferred.

  • Advanced ability to work both independently and in a global cross-functional multicultural and international team.
  • Excellent understanding of system data structures and Clinical Document Management System functionality
  • Excellent attention to accuracy and details
  • Excellent communication, organization and tracking skills.
  • Strong operational skills and demonstrated ability to meet timelines. *Ability to resolve issues with minimal supervision and understand when to escalate
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