Clinical Site Leader - Various locations through Europe
- Experience Level
- Experienced (non-manager)
This role will see you with direct responsibility for all site activities for the European aspects of these pivotal Phase II studies.
You will have involvement with all aspects of the site selection, set-up and initiation, patient recruitment and on-going monitoring activities across a network of sites throughout Europe. This is a role very different from the normal Lead CRA-type role and is genuinely one of a kind.
If you are looking to build upon your solid monitoring career to date and have a strong oncology monitoring background, please get in touch as soon as possible.
- Responsible for the successful start-up, monitoring and execution of studies at assigned clinical sites
- Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
- Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
- Arrange for monitoring availability and ensure data entry timelines are maintained at responsible sites
- Develop and cultivate strong site relationships and ensure continuity of site relationships
- Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
- Identify, assess, escalate and resolve site performance or quality issues in a timely manner
- Complete feasibility and site identification activities for new clinical studies
- Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
- Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
- May be involved, when needed, in other areas of study management and staff training
- Life science degree (or equivalent)
- Minimum 3 years of independent site monitoring experience
- Previous experience within oncology studies
- Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall global drug development
- Thorough understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations
- Ability to travel up to 50-65%
This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.
To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.
Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.
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