Clinical Trial Associate (m/f)

Description

• Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with Novartis processes
• Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary
• Interactions with Investigator sites e.g. to collect relevant documentation, provision of study materials / documents
• Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups
• Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g. internal CTL meetings or external investigator meetings. May attend and present at these meetings as appropriate
• In collaboration with the Trial Document Specialist responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines
• Maintenance of knowledge and training of ICH-GCP, current regulations and procedures

• Previous experience in clinical trials (e.g. clinical trial design, execution and operations) is preferred but not required
• Good organizational and interpersonal skills
• Ability to work in a team as well as independently if required and to manage multiple priorities with support
• Computer literate