Zaměstnání - Nabídky

CRA / Study Manager

Typ práce: hlavní pracovní poměr

We are looking for a candidate who will be responsible for logistics, coordination and timely conduction of clinical studies in phase II-IV. He/She will also provide accurate and valid data delivery on time for further statistical evaluation and clinical report.

 Monitor and support clinical trials (II–IV phase) in the Czech republic
 Prepare relevant study documents for local and international Authorities
 Select clinical sites, arrange the local logistic system and procedures of the clinical trial, conduct recruitment strategy and initial visits.
 Conduct of the monitoring activities in selected centers and coordinate outsourced monitoring of particular studies, review and approve monitoring reports.
 Responsible for compliance with the rules of ICH-GCP.
 Responsible for obtaining the necessary translations of the documents related to the study (e.g. SIS/IC, diary cards, questionnaires).
 Follow up of current developments in the field of clinical research, participation in the general and project-specific trainings.
 Justify and negotiate the budget and define time schedule for specific parts of the trial.

Requirements

 University degree in medicine, pharmacology, pharmacy, medical biology, biochemistry or comparable education.
 Minimum 3 years of the practical monitoring experience.
 Experience in Epidemiology, Public Health is an advantage.
 Significant knowledge of ICH-GCP.
 Ethical behavior.
 Flexible and creative approach to problem solving.
 Detail orientation, focus on precise preparation and execution of the trials, analytical skills, timely manners.
 Reliability .
 Very good communication, negotiation and organizational skills.
 Fluent in written and spoken English language is a must.

Client offers

 Background of international original pharmaceutical company.
 Trainings and professional development.
 Fascinating work within experienced community.
 Challenging and responsible role.
 Competitive remuneration package.