Clinical Trial Associate (CTA)

Major accountabilities:

• Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
• Sets-up systems
• Supports vendor selection, TPRM process, SIM entries
• IF and TMF management (country and site TMF); set-up and maintenance according to
  regulatory and Novartis requirements; document oversight and tracking
• Supports Vendor set-up as applicable
• Checks site “Green Light” completeness and ensures all documentation is in place for initial
  and subsequent drug release in collaboration with the local Qualified Person(s)
• Supports preparation and translation of ICF into local languages (including vendor management if necessary) and preparation of patient facing material
• Responsible for completeness of uploaded trial related documents into CREDI/SUBWAY,
  including archiving of paper TMFs
• Supports country SSU strategy in close collaboration with SSU Team Lead and SSU Managers
  to ensure SSU timelines and deliverables are met according to country commitments
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
  Authority and SOP requirements
• Provides logistic support to SSU CRA, CRA, CPM, SSU Manager in all phases of the clinical trial

What you will bring to the role :

• Commercial or medical training (e.g., vocational qualification, bachelor’s degree), Medical records administrator or equivalent education, preferably with experience in clinical operations
• Ideally several years of working experience with 1+ years´
  of experience in clinical operations
• Understanding of clinical drug development with
  particular emphasis on trial set-up, and contracting

Desirable requirements:

• Strong process and system understanding
• Ability to prioritize and high coordination skills
• Demonstrated collaboration and communication skills

You’ll receive:

• An attractive salary
• An annual bonus
• A focus on your career development
• Access to our Quality of Life at work program
• Flexible working
• Advanced social coverage for you and your loved ones
• 27 days of paid leave & 14 days of RTT per year
• Various employee recognition programs