Clinical Study Manager - Biotech - Remote
NonStop are currently partnered with an Italian Biotech who are looking for a Clinical Study Manager, on a contract basis for 3-4 months at least, which can be worked from home. The beauty of this is that it is a full time role and due to the duration outside of IR35.
The company is specialised in rare diseases, with a strong pipeline and therefore growing a lot, which could lead to further internal opportunities or extensions. Here is a brief overview of the role below:
Responsible for the following activities:
- Supervision of CRO and vendors.
- Ability to set and meet activities and project timelines, according to corporate goals.
- Co-monitoring visits at the sites (up to 20-25%).
- Oversight of monitoring activities, such as review of monitoring visit reports, protocol deviations and site action items
- Manage screening and recruitment activities to ensure timely enrolment.
- Perform ongoing data review.
- Liaise with drug safety and medical monitors for safety issues and SAEs.
SKILLS AND EXPERIENCE
- Knowledge of the fundamentals of Clinical Development and experience in project and clinical management.
- Strong monitoring background.
- Strong knowledge of ICH GCP (valid certificate of training is required).
- Good working knowledge of Microsoft Office.
- Knowledge and experience with Clinical electronic tools such as eCRF, IWRS, eTMF.
- Experience in Medical devices is a plus.
- Experience with orphan disease and/or neurology would be an asset.
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or 0207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.