Project Manager

Roles and Responsibilities
Managing of clinical trials including
Attainment of agreements with sponsor regarding execution of projects
Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects
Interface management
Management and co-ordination of CRAs:
Coordination of individual steps of national or multinational multicentre trials
Supervision of GCP compliance (e.g. giving "green light" for study initiation)
Supervision of the ongoing clinical part of a trial, as regards monitoring, safety aspects, timelines, and costs
Supervision of study termination
Prospective troubleshooting (e.g. communication of relevant issues turning up during the clinical part and respective decisions in a timely manner to all relevant parties)
Transmission of information and discussion of the course of the project with the sponsor/DCO (Director Clinical Operations)
Cooperation with data management, biometrician and medical writing, medical services and pharmacovigilance, quality assurance, training
Participation in in-house inspections and/or audits (internal and external)
Responding to audit/inspection reports
Establishment of CAPA as applicable
Requirements
Experience in clinical research (preferably in a CRO)
A natural science degree or a pharmaceutical or medical degree is of advantage
At least one year experience in planning, conducting, supervising and evaluating clinical trials
The ability to think analytically and a talent for organising are required
Ability to comprehend regulatory structures and procedures
Ability to make oneself familiar with specific medical issues (e.g. study indications, symptoms, and methods for assessment of clinical parameters)
Understanding of biometrical hypotheses/strategies
Very good command of written and spoken English
Excellent organisational skills and team leading skills
Location