Entry level position for a science graduate with an interest in starting a career in clinical trials

Clinical Operations Assistant

Overview of Role

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 position also provides local administrative support in Switzerland, including filing, office administration, and coordination of notarized and apostilled documentation

Key responsibilities and minimum requirements according to job level:

• 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

Competencies required to fulfill the employee responsibilities and work assignments:

• An employee shall follow the job description that pertains to the position. In addition, an employee shall follow the SOPs that pertains to the position.

• An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado.

• 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.

• Capable of being innovative and dynamic in approach to work.

• Capable of performing other duties as assigned by management.

• Work collaboratively and effectively with a wide range of people.

Specifics of the role:

• Basic interest, knowledge and understanding of the drug development process.

• Basic understanding of the principles of ICH-GCP and Declaration of Helsinki

Minimum education and experience required for the role:

• Bachelor’s Degree in Scientific field, advanced degree advantageous

• Some relevant work experience is preferred.

• Familiarity with regulations governing clinical research and ICH GCP guidelines is a plus.

• 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. Knowledge of Nitro, Miro, Asana, SAP and Veeva systems is an advantage.

• Willing and able to travel occasionally.