Alvotech hf
Alvotech hf
Alvotech hf

Clinical Operations Manager

Alvotech is looking for a Clinical Operations Manager for a 12 month temporary position to support clinical development projects. The role involves overseeing the implementation of clinical trials, ensuring execution within budget constraints and quality standards. As the primary liaison between internal teams and external partners, the individual will facilitate collaboration and maintain oversight of the research process. This is a unique opportunity to contribute to innovation within the pharmaceutical industry in a dynamic work environment.

Key Responibilities:

  • Manage assigned clinical trials, ensuring delivery on time, within budget, and GCP standards.
  • Oversee trial operations, including Trial Master File (TMF) maintenance, invoice verification, and essential document updates.
  • Coordinate internal teams and act as the main contact for CROs, vendors, and sites to ensure sponsor oversight.
  • Report trial progress and escalate critical issues to Clinical Operations leadership.
  • Contribute to protocol development, regulatory documentation, and operational planning.
  • Support trial forecasting, supply management, and continuous process improvement.
  • Ensure compliance with ICH-GCP and internal SOPs and stay updated on regulatory changes.


Qualifications:

  • A master’s degree or higher in a relevant scientific field. A Pharm.D. or Ph.D. is a plus but not required.
  • Solid experience in clinical operations, preferably within the pharmaceutical or biotech industry, or a Clinical Research Organization (CRO).
  • Proven expertise in clinical trial management across Europe, the US, or Asia-Pacific regions.
  • Strong knowledge of GCP, ICH guidelines, and regulatory environments (EMA/FDA).
  • Experience with biological or biosimilar drug development is a plus.
  • Exceptional communication, organizational, and teamwork skills.
  • A collaborative mindset with the ability to manage multifunctional teams.
  • Fluent in English (written and verbal); additional languages are a plus.
  • Willingness to travel internationally as required by trial activities.


What we offer:

  • An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
  • The chance to be a part of a global and fast-growing company.
  • An international work culture that encourages diversity, collaboration and inclusion.
  • Positive, flexible, and innovative work environment.
  • Support for personal growth and internal career development.
  • Company social events and milestone celebrations.
  • Excellent in-house canteen and coffee house.
  • Exercise and wellbeing support for full-time employees.
  • On-site shower facility.
  • Transportation grant towards eco-friendly modes of travel for full-time employees.
  • Internet at home for full-time employees.


Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Auglýsing birt13. júní 2025
Umsóknarfrestur25. júní 2025
Tungumálahæfni
EnskaEnska
Nauðsyn
Mjög góð
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar