Senior Global Clinical Trial Associate
Brine SA
Zurich, Switzerland
vor 3 Tg.

Major Accountabilities

  • Support the definition and refinement of the document management strategy for Documentation within a defined area of Clinical Development.
  • Design and / or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area.
  • Manage system and / or process Implementation in collaboration with Business and IT Functions.

  • Act as Business Analyst / Lead to manage the implementation of Document Management Related Applications :
  • o Support definition and orchestrate business requirements across NVS and identify achievable business Benefits

    o Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected

    o Support the design of training concept(s) and training material

    o Provide input to technical teams for migration and support migration testing

    o Plan, prepare and oversee rollout and change management activities (communication and training)

  • Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
  • May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with sys-tem support and business functions.
  • May act as Business System Owner or deputy for an eDMS or eDMS-related software application.
  • The above responsibilities are to a large extent based on interdisciplinary topics and require the employee to liaise, cooperate with and coordinate numerous related functions such as internal Clinical Operations functions, CRO representatives, IT.

    Job Dimensions :

    Compliance of GCP relevant documentation as well as efficiency of related processes :

  • Timely submission, delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
  • External satisfaction, acceptability of clinical documentation by Health Authorities.
  • Efficient use of resources through operational effectiveness of document management and archiving
  • External reputation of NVS clinical documentation, with Health Authorities and in the document management and archiving community in general
  • Education :

  • Minimum Bachelor’s degree in life science / healthcare or equivalent
  • Experience :

  • Thorough knowledge of clinical document management processes
  • Advanced knowledge of clinical documentation best practice guidelines & principles
  • good documentation practice, data integrity)

  • 3-5 years in clinical development / clinical operations or similar business area
  • 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
  • Good understanding of technical processes and PC environment including Microsoft suite of products
  • Advanced ability to work independently
  • Experience with project work or project management in a global, cross-functional
  • multi-cultural and international matrix organisation

  • Excellent communication, organization and tracking skills
  • Work location : Basel

    Workload : 100%

    Salary : to be discussed

    Language : Fluent English (oral and written), German of advantage

    Ref : EW2626

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