Rontis, a Swiss multinational healthcare company, is looking to hire:
Clinical Operations Scientist
based in Athens, Greece.
Role Description Summary:
Responsible for Bioequivalence/Clinical studies. The Clinical Operations Scientist is expected to coordinate all sites and vendor (e.g. Clinical Research Organization) related issues with supervision from the R&D Director.
- Coordinates Bioequivalence/Clinical studies
- Coordinates clinical study operational plan and CRO activities including project timelines & quality of deliverables
- Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
- Reviews clinical operational plans including the study monitoring plan and other plans as needed
- Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports, monitoring reports, scientific literature
- Participates in study data review and other review activities as assigned
- Contributes to the submission of trial-related and essential documents to the Trial Master File
- Collaborates with R&D team during compilation of clinical trial application documents (CTA) and/or any related study activities
- Work closely with other teams in the organization, e.g. quality, regulatory, CMC etc. during regulatory submissions
Job Qualifications & Requirements:
- Bachelor of Science or master’s degree in life science or related field (or equivalent experience)
- Minimum of 2 years of clinical research experience
- Thorough understanding of FDA, ICH and GCP guidelines
- Team oriented with excellent cross-functional collaboration and participation skills
- Excellent interpersonal, verbal and written communication skills
- Knowledge of computer programs including Microsoft Office suite
This is a full-time position.
Only candidates meeting the criteria above will be contacted
Candidates are kindly requested to send their CV.
[To send your CV please click here.]