Job Overview :
Join as of now Covance's exceptional teams and help us improve the lives of millions of patients around the world!
Covance is currently recruiting a Submission Specialist to beoffice-based in Vienna, Austria. For the right candidate there is some flexibility to work part office based and part home based.
This role is open to CRA with regulatory submission experience in Austria and looking for their next career step.
At Covance, you’ll redefine what’s possible and discover your extraordinary potential. You’ll have the opportunity to personally advance scientific research and make a difference in peoples’ lives with your bold ideas and unique point of view.
We are looking for a Clinical Operations Manager (Study Start Up) to be office based in Vienna (with potential for some home working) and working for one of our clients.
Primary contact with assigned investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC / IRB and any other local applications are made within the timelines agreed with project management and Start-up team and that documentation meets the specifications required by applicable regulations and sponsor.
Serve as local expert in project start-up activities for a particular country or region.
Act as a knowledge resource’ to mentor and train new hires and less-experienced department colleagues.
Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and applicable laws and guidelines
Prepare submissions to IRB / IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB / IEC and / or regulatory authorities (if applicable) regarding submission / approval issues.
Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making it ready for an audit at any time
Education / Qualifications :
Degree in life sciences OR equivalent experience in similar position
Fluent / Excellent knowledge in German and English
Valuable experience in clinical development or start up / regulatory process.
Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines; familiarity with investigator start-up documents and ideally contract / budgets negotiation process;
previous interaction with operational project teams and investigative sites
We look forward to your application!