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Clinical Operations Specialist

vor 1 Woche

Stäfa, Zürich, Schweiz TN Switzerland Vollzeit

At TN Switzerland, we are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Zurich.

Main Responsibilities:

  • Support the timely delivery of clinical investigations in collaboration with study-assigned Clinical Research Managers (CRMs).
  • Maintain adherence 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 (SDV) and timely query resolution.
  • Assist in investigation start-up activities, such as site selection visits and review of regulatory documents.
  • Establish and maintain regular contact with investigators and ethics committees as needed.
  • Prepare and maintain investigator files, center files, and study master files.
  • Communicate project-specific information to/from trial sites and document communication with investigation sites/teams.
  • Present at and participate in investigator meetings, other study trainings, and meetings as assigned.
  • Support statistical evaluation of study results within clinical operations.
  • Ensure timely delivery of clinical documentation needed for product development projects, such as clinical investigation reports.
  • Screen and identify business- and product-relevant scientific literature as assigned.

Job Requirements:

  • A medical-related scientific degree, such as Bachelor or Master qualifications.
  • Strong knowledge of ISO 14155 GCP and ICH-GCP Guidelines.
  • Minimum 1-2 years of experience in various clinical trial activities within a medical device industry, preferably in dentistry.
  • Knowledge of the dentistry sector and a strong scientific understanding are preferred.
  • Good interpersonal skills.
  • Ability to work both independently and collaboratively within a team.
  • Fluency in English (reading and writing); any additional language is an advantage.
  • Strong interest in data analysis, graphing, and plotting results, as well as report writing.
  • Willingness and ability to travel, as required (25%).