Nobel Biocare is an innovation leader in the field of implant-based dental restorations. We offer a dynamic and inclusive environment that fosters creativity and collaboration within our global workforce. We strive to provide the highest-quality implant solutions and workflows, enabling our customers to deliver optimal patient outcomes, while fostering practice growth. We embrace our position as a leader in the premium segment and uphold the highest standards in the dental industry. With a commitment to developing our talented workforce, Nobel Biocare is a great place to build your career. For more information about Nobel Biocare, visit www.nobelbiocare.com
To strengthen our Teams in Zurich-Kloten we are looking for a
The role is to support the study assigned CRM in preparing and monitoring and close out of clinical studies (Internal T-Studies and larger External IITs).
Compiling of business and product relevant scientific data/literature incl. writing of reports in collaboration with supporting CRM.
Note! The role may be assigned to fully manage smaller IIT and retrospective data collection projects not subject to clinical study standards and regulations.
Organizes and manages clinical trials specific tasks, e.g. clinical site compliance, development of trial protocols and completion of study submission for regulatory approval.
- Support timely delivery of clinical investigations in collaboration with study assigned CRM
- Adhering to required quality standards and laws/regulations
- Independently perform monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits
- Ensure Source Data Verification and timely query resolution
- Assist in investigation start-up activities, e.g. site selection visits and completion/review of regulatory documents
- Establish and maintain regular contact with investigators, ethic committees as needed
- Prepare and maintain the investigator file, center file and study master file
- Communicate project-specific information to/from study sites and documents communication with investigations site/teams and escalate issues to CRM in a timely manner
- Present at and participate in investigator meetings, other study trainings and meetings as assigned
- Support statistical evaluation of study results
- Support timely delivery of clinical documentation needed in product development projects, e.g. clinical investigation reports
- Screening and identifying of business and product relevant scientific literature as assigned
- Medical related scientific degree (Bachelor, Master, Nursing qualifications)
- Profound ISO 14155-GCP experience and monitoring
- In-depth knowledge in clinical research/investigation methodology
- English fluent written and spoken, any other language is an advantage
- Experience in medical device field of at least 1-2 years (preferably dentistry) ?