Clinical Operations Assistant

Entry level position for a science graduate with an interest in starting a career in clinical trials. The Clinical Operations Assistant provides administrative and operational support to the Clinical Operations and Clinical & Medical Affairs (CMA) teams in accordance with ICH-GCP, Alvotech SOPs, and applicable local regulations. The role supports the efficient execution of clinical studies through document management, meeting coordination, training administration, study tracking, and other operational activities. The role requires fluency in both English and German.

Responsibilities

Provide administrative support to the project teams in clinical operations in accordance with ICH-GCP, Alvotech SOPs and local regulations; Assist in the set-up and review of study related documents trackers; Collaborate with Clinical and Medical Affairs (CMA) team to assist with revisions of department SOPs; Facilitate study or program clinical meetings with respect to the preparation and distribution of materials and final meeting minutes, as well as the coordination of participants; Assist Clinical Operations Team in the production of study reports and updates; Assist in the tracking of study activities and metrics as needed; Coordinate training curricula and requirements for the CMA department; Review the Trial Master File (TMF) status ensuring compliance with ICH GCP and EU-CTR regulations and review and maintain Sponsor-related TMF document according to Alvotech SOPs and work instructions; Liaise with all Alvotech departments/affiliates ensuring that all study documentation is filed appropriately; Triage study-specific information to Clinical Operations team members who are traveling; Support Head of Clinical and Medical Affairs on local administrative matters and ad-hoc activities; Assist with corporate administration activities according to need and availability; Attend and participate in internal and external training sessions; Assist Director or Manager Clinical Operations during co-monitoring visits; Support of Vendor Management and Clinical Supplies activities

Requirements

Bachelor's Degree in Scientific field; Basic interest, knowledge and understanding of the drug development process; Basic understanding of the principles of ICH-GCP and Declaration of Helsinki; Excellent organizational and problem-solving skills with good attention to detail; Excellent interpersonal and communication skills in English and German language (writing, speaking and understanding); Proficiency with computers and Microsoft Office Suite including Word, PowerPoint, Outlook, Excel, Acrobat, and strong focus in Microsoft Teams; Strong organizational skills; Good communication skills; Computer literacy including MS Word, Excel, PowerPoint and Outlook; Able to work independently and as part of a team; Able to maintain high ethical standards of integrity and quality; Willing and able to travel occasionally; This role is open to candidates who are already based in Zurich, or have the right to work in Switzerland. Relocation is not considered

Nice to have

Some relevant work experience is preferred; Advanced degree advantageous; Familiarity with regulations governing clinical research and ICH GCP guidelines is a plus; Knowledge of Nitro, Miro, Asana, SAP and Veeva systems is an advantage