Expert Clinical Trial Documentation - Clinical Trial Associate (CTA)

Market-related salary and benefits package

Your main tasks and responsibilities Set up and maintain Trial Master Files (TMFs) and lnvestigator Site Files (ISFs) according to Octapharma SOPs Support the Clinical Team in preparing clinical trial documents and documentation for regulatory submissions Track clinical trial documents such as insurance certificates, confidentiality agreements and study contracts throughout the trial lifecycle Maintain audit and inspection readiness through periodic review of TMF accuracy and completeness, quality control checks, and a unified TMF management approach. Support audits and inspection preparation and execution with regards to the TMF Act as a central contact for trial documentation, designated project communications, support ad hoc tasks Manage returning/archiving of TMF documents Assist in the organization of lnvestigator Meetings Perform various administrative tasks to support team members with clinical trial execution, as required (e.g. literature search or document formatting review for regulatory submissions) In addition, for the senior position: Assume Data Protection / Information Security Champion responsibilities Assists in development of SOPs Perform vendor evaluation and oversight for selected vendors

Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation. Join us in shaping our vision to provide new health solutions advancing human life.