Global Clinical Operations Lead; m/f/d
Listed on 2026-06-11
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Science
Clinical Research, Medical Science
Location: Luzern
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 RoleWe are seeking an experienced and proactive Global Clinical Operations Lead (f/m/d) to manage and oversee clinical trials/clinical studies/clinical investigations from initiation to close-out. This role will work closely with GC cross‑functional project teams, investigators, and Contract Research Organizations (CRO) to ensure that studies are conducted in compliance with applicable regulatory requirements, Good Clinical Practice (GCP), and applicable institutional policies. Key responsibilities include ensuring the protocols are prepared and ensure that endpoints are aligned 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/clinical studies/clinical investigations, the integrity of clinical data and the safety and well‑being of study participants.
with an initial primary focus on Europe, responsible for establishing and overseeing clinical operations processes in compliance with EU Medical Devices Regulation (MDR) 2017/745 and following the applicable ISO requirements.
Key Responsibilities Study Coordination- Prepare the study protocol; establishment of endpoints and sample size.
- Manage the day‑to‑day operations of clinical trials/clinical studies/clinical investigations, 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.
- Ensure that clinical investigations appropriately address clinical practice considerations, statistical requirements, and applicable regulatory obligations throughout planning, conduct, and reporting.
- Leverage qualified internal and external subject‑matter experts such as clinical experts, biostatistics, Regulatory Affairs, CROs as necessary, while retaining overall responsibility for the adequacy and integration of their contributions into the clinical investigation.
- Prepare and maintain regulatory documents, Investigator's Brochure (IB) submissions, and study logs.
- Ensure compliance as applicable with GCP as per ISO 14155:2026, EU MDR 2017/745, and applicable local regulatory requirements.
- Able to collect, enter, and manage clinical data in electronic data capture (EDC) systems provided by the CRO.
- Monitor data quality and resolve discrepancies in collaboration with data management teams.
- Coordinate site visits, audits, and monitoring activities with CRO.
- Maintain study supplies, equipment, and documentation in audit-ready condition.
- Liaise with investigators, sponsors, CROs, and internal departments to ensure compliant study execution.
- Participate in study meetings, training sessions, and protocol reviews.
Required Qualifications
- 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.
- Strong…
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