With all the uncertainty in the world, your job stability should not be a concern.
Covance have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. But we are much more than a normal CRO: We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined Our Early Phase Solutions have proved to shave off 30 % time from lead candidate to Proof of Concept LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.
Covance Phase IV Solutions has a truly compelling story to tell: 2020 CRO Leadership Award for Late Phase, 220+ Global Studies in less than 5 years and we are growing.
This is where you come in: we have opened a Remote Site Monitor/ CRA job to support the growth expected in the PhIV, Non-Interventional Studies area in Europe .
Join us and see why Covance are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
This is a permanent , full time job.
Due to our expansion, our ideal locations are: Germany, Italy, Belgium,Netherlands, Nordics, Poland
Depending on each location, you could work office based or with a combination between home & office .
On a normal day, you will find yourself providing your support with feasibilities , and we will trust you to be Covance´s main primary contact for sites and to drive the collection, tracking and quality review of all essential & investigator documents, supporting EC Submissions .
You will perform all the remote monitoring activities (SQVs, SIVs, routine), report writing , follow up queries with sites and site closure activities, working in close cooperation with the trevelling CRAs.
To thrive in this job, you must: Be a site-relationship builder : you are experienced in getting sites to provide you with the documents you need on time (and with non-responsive sites, you know how to balance the “push” with being friendly) Be our client confident : when they raise questions, you know how to ask, listen and really understand their need, and you know how to answer them in an exact and diplomatic manner too.
Education/Qualifications: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considere Thorough knowledge of ICH Guidelines, GCP and GPP including a basic understanding of regulatory requirements in other countries. Thorough understanding of the drug development process. Fluent in local office language and in English, both written and verbal
Experience: Minimum of four (4) years clinical research experience of centralized and/or on-site monitoring Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Advanced study site management skills Advanced registry administration skills Ability to work with minimal supervision Good planning and organization skills Good computer skills with good working knowledge of a range of computer packages Advanced verbal and written communication skills Ability to train and supervise junior staff Ability to resolve project-related problems and prioritizes workload for self and team Ability to work within a project team Works efficiently and effectively in a matrix environment
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