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Global Clinical Operations Lead

vor 3 Wochen

Luzern, Luzern, Schweiz GC International AG Vollzeit

Who We Are

GC International AG, based in Lucerne, is a global leader in dental care and oral health. With more than 100 years of history, presence in over 100 countries, and a team of over 3,500 people worldwide, we are proud to support dental professionals with innovative, high-quality products that truly make a difference for patients.

Our teams across Europe, North America, and Asia work together to develop and manufacture precision components for the dental industry, always focused on quality, innovation, and improving lives.

At GC, we believe in working with care and purpose. Our company philosophy, SEMUI, is all about thinking from the standpoint of others, whether that's our customers, our teams, or the people who use our products every day. It's this mindset that helps us drive innovation, respect each other, and create real value for the future of oral health.

If you're looking to join a successful, global company with real career opportunities, we'd love to meet you.

About the Role

We are seeking an experienced and proactive
Global Clinical Operations Lead (m/f/d)
to manage and support clinical trials from initiation to close-out. This role will work closely with GC cross-functional project teams, investigators, and Contract Research Organizations to ensure that studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and institutional policies. Key responsibilities include ensuring the protocols are prepared and ensure that end-points are in agreement with the requirements for approval and for feasibility evaluations. Reporting to the Chief Technology (R&D) Officer, this role is critical in ensuring the timely execution of clinical trials, the integrity of clinical data and the safety and well-being of study participants.

This is a global role with an initial primary focus on Europe, responsible for establishing and overseeing clinical operations in alignment with ISO requirements, while progressively expanding to include oversight of U.S. clinical activities.

Key Responsibilities

Study Coordination

  • Prepare the study protocol, establishment of endpoints and sample size.
  • Manage the day-to-day operations of clinical trials, including patient recruitment, informed consent, scheduling, and follow-up and management of CROs.
  • Serve as the primary point of contact for study participants and CROs and ensure adherence to study protocols.

Regulatory Compliance

  • Prepare and maintain regulatory documents, IRB submissions, and study logs.
  • Ensure compliance with GCP, ICH guidelines, and local regulatory requirements.

Data Management

  • Collect, enter, and manage clinical data in electronic data capture (EDC) systems.
  • Monitor data quality and resolve discrepancies in collaboration with data management teams.

Site Management

  • Coordinate site visits, audits, and monitoring activities.
  • Maintain study supplies, equipment, and documentation in audit-ready condition.

Team Management, Collaboration & Communication

  • Liaise with investigators, sponsors, CROs, and internal departments to ensure smooth study execution.
  • Participate in study meetings, training sessions, and protocol reviews.
  • Gradually build and lead a high-performing global clinical operations team, overseeing hiring and team development across Europe and the U.S.

Your Profile

  • Preferably master's degree in medical or life sciences, public health, or a related field; alternatively, a Bachelor's degree in the same disciplines.
  • Minimum 5-10 years' experience in clinical research or similar role and proven track record managing clinical trials in Europe and US.
  • Mandatory experience in the medical device industry and standards.
  • Strong knowledge of clinical trial processes, GCP, and global regulatory guidelines including ISO13485 and ISO14115.
  • Excellent organizational and time management skills.
  • Strong interpersonal and communication skills.
  • Proficiency in Microsoft Office and clinical trial management systems.
  • Excellent command of English is required; knowledge of additional languages will be considered an asset.
  • Willingness to travel internationally as required

Why Join GC International AG

At GC International AG, you will be part of a growing, innovative company with a global footprint. We offer a collaborative, international work environment where your expertise makes a direct impact.

Ready to Apply?

We look forward to receiving your application. Please note that due to the high volume of applications, only shortlisted candidates will be contacted. Thank you for considering GC International AG as your next career step.