2 days ago

Clinical Trial Manager

Alvotech Swiss AG

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Clinical Trial Manager

Alvotech is a privately owned biopharmaceutical company focused on the development and
manufacturing of high quality biosimilars for global markets. At Alvotech, our goal is to become a
global leader in the biosimilar space and to deliver high quality and cost competitive products to
our partners and to patients worldwide.

Our product development pipeline is developed in Research & Development centers across
Europe and will be manufactured in our state-of-the-art facility located in Reykjavik Iceland.

Within Alvotech Switzerland we are currently recruitung a
Clinical Trial Manager
Main Function: The Clinical Trial Manager (CTM) will be responsible for the operational and logistic aspects of the assigned clinical trial(s). Within this role, the CTM will be responsible for
adhering to regular planning of tasks in accordance with clinical program timelines, performing the
required activities to keep the assigned clinical trial(s) on budget, on time and with the highest
standard of quality. In addition, the CTM will have to establish day-to-day interactions with the Contract Research Organizations (CROs) and trial sites to ensure sponsor’s oversight
Most important tasks of the job: - Implement, monitor, supervise and direct the assigned clinical trial(s) - Ensure all trial deliverables are met in accordace with timelines, budget, operational
procedures and quality / GCP standards - Maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and internal
Standard Operating Procedures (SOPs) - Provide input on relevant part of the clinical trial essential documents (e.g. protocol, Informed
Consent Form, Investigator’s Brochure) - Provide input on relevant section of regulatory meetings (e.g. briefing package) - Prepare and share information (e.g. PowerPoint slides, Word document, Excel Spreadsheets)
about clinical trial updates for internal and external team meetings (e.g. regular updates, CRA
training, Investigator’s meeting) - Coordinate both internal and external Clinical Team meetings - Support Clinical Project Management activities when necessary - Keep tracking of trial budget, reviewing and approving invoices - Ensure the trial is conducted in compliance with relevant policies, internal Standard Operating
Procedures (SOPs), and Working Instructions (Wis)

The primary location for this role is Alvotech‘s office in Zurich. It is expected that Clinical Trial
Manager will have to travel internationally, as required by the Clinical Trial activities.
Organizational Structure: - The Clinical Trial Manager will report to and will be supervised by the Head Clinical
Operations, within the Clinical Development Department.
Qualification and Experience:
Education: Master of Sciences

Languages: Fluent in English, both written and verbal. Any additional language is a “nice to have“.

Knowlegde: Proficient in use of a PC and common Microsoft packages such as Word, Visio,
Excel, Powerpoint. Good knowledge of GCP and other relevant ICH/regulatory guidelines.

Experience: 5+ years in relevant functions in the Pharmaceutical Industry, or equivalent. Proven
ability to interact collaboratively in a cross-functional environment required. Subject matter
expertise in Clinical Operations and related activities. Previous experience conducting clinical
trials in Europe/US and some Asia-Pacific regions in an outsourcing model is necessary, along
with a working knowledge of the EMEA and FDA clinical/regulatory environment.

As a team player you manage to build a team spirit. You are tolerant and considerate to be an
active and open communicator and share knowledge and experience with other team members.
You have a hands – on attitude as well as a result-orientated way of work. You coordinate,
participate and make positive contribution to team meetings.
We offer: To be part of a growing team dedicated to improving access-to-medicine, we offer opportunities
to bring forward ideas, lead change and ongoing opportunities for personal development and
growth in an international company.

Candidates should apply to Jozefina Mijatovic (Ms.): jozefina.mijatovic@alvotech.com Join our Alvotech team and be part of our growth!