Zaměstnání - Nabídky

Clinical Operations Manager

Typ práce: hlavní pracovní poměr

We are looking for a candidate who will supervise clinical studies in phase II-IV by leading the team of 9 CRAs and Study Managers in Czech Republic. He will be the most important realization and communication point of contact for clinical trials within the organization, towards headquarters and internal and external partners.

Key Responsibilities
 Responsible for the organization, monitoring and management of all client’s clinical trials performed from planning via initiation through to completion, in accordance with relevant international and local regulations, ICH-GCP and current SOPs.
 Supervises CRO monitoring activities regarding clinical trials locally.
 Responsible for manpower planning, recruitment, appraisals, progress and adequate training and coaching of all subsidiary personnel as well as CRAs sent on secondment by CROs.
 Responsible for quality control activities performed locally.
 Supervise of reporting SAEs in accordance with SOPs and local regulations and requirements.
 Assist in planning and conduct of internal and external audits, follow-up on the audit reports.
 Follow up on 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 local activities connected with trials.
 Point of contact for internal and external partners and headquarters for all clinical trials in Czech Republic.

Requirements

 University degree in medicine, pharmacology, pharmacy, medical biology, biochemistry or comparable education.
 Minimum 3 years of the managerial experience within clinical trials area.
 Experience in Epidemiology, Public Health is an advantage.
 Significant knowledge of ICH-GCP
 Ethical behavior
 Leadership skills, team spirit.
 Flexible and creative approach to problem solving.
 Detail orientation, 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.