Description
Global (CRA) Role Global Pharmceutical Pharma Vienna Austria
You will be responsible for the execution of our phase III clinical studies, mainly with regard to operational and administrative aspects. This implies the preparation and processing of international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You will be responsible for the timely performance of all services, control of third party providers, as well as problem management by interacting with all departments involved.
SRG Clinical are currently supporting a global Pharma company business to appoint a Global CRA In House ( 20% International travel ) to be office based in Vienna and wondered if this would be of interest to you?
In this role you will not be married to one function but be involved in helping on the project, feasibilities and much more
In this role German is not required
This would be an excellent opportunity Typically the travels take place every 4-5 weeks for up to 3 days at a time, the rest is done in-house in managing CRO CRA's
This would be a very good chance for the right candidate to progress into a global environment and away from your daily regional role with constant monitoring visits
This is a very good company, has made many new acquisition and has loads of new projects on the start-up phase
Functions
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Oversight on project timelines, quality and deliverables
Co-Monitoring
Support in preparation of regular status reports to the management
Contribution to and review of study documents, e.g. synopsis, investigator's brochure, patient informed consent documents, site instruction departments
Preparation and conduct of project trainings
Training CRO CRA's on Sponsor Protocol and SOP's
Organisation and participation in investigator meetings
Generation of a project database
Protocol writing
Processing of all relevant issues of international ethics committees and regulatory authorities in adherence to the timelines
Effective internal and external project communication
Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
Minimum 2 years of experience, Co-monitoring ,regulatory submissions (not essential training will be given), monitoring of clinical trials or clinical trial assistance
Refined colloquial and correspondence skills in English (written and spoken)
Fluent in English (written and spoken)
Experience in usual software (Word, Excel, Power Point, MS Project)
Ready to take over responsibility, pro-active way of working
Able to motivate and lead a team / used to work in a team
Excellent organisational skill
Please ONLY apply if you can work in the EU, allow 24 hours for feedback
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
