ProClinical is currently seeking a Regional Clinical Site Lead for a leading global CRO based in Rome, Italy. The Regional Clinical Site Lead is responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws and Good Clinical Practices.
- Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleague, and with input from external clinical experts as required. Applies clinical development strategy in the assessment of country and site selection at the asset level
- Provide recommendations on potential sites and provide targeted follow up with key sites as required.
- Oversee and support study start up activities at the country level, including review of key documents (eg local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.
- Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation.
- Provide enrolment support and ensure progress by responding to start-up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level
- Lead effective site recruitment planning and implementation of plans at the country and site level, consistent with global plan and local specificities
- Support database release as needed.
- Be proactive in ensuring overall site quality, regulatory and GCP compliance.
- Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors.
- Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other RCSLs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks.
- Create and manage (the study oversight plan) and mitigate for known/anticipated risks proactively.
- Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc) and take appropriate targeted action.
- Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control.
Skills and Requirements:
- Medical Degree (Must)
- Extensive knowledge of clinical trial methodologies
- Must be fluent in English. Multi language capabilities are an advantage in this role.
- Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
- Demonstrated knowledge of global and local regulatory requirements
- Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)
- Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
- Demonstrated ability to participate and support sponsor regulatory interactions/inspections
- Demonstrated knowledge of the processes around protocol design and feasibility assessment
- Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
- Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
- Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Availably to travel within region and/or globally as required
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Francesca D'Arpa on +44 207 440 0630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.