For one of our clients, a leading pharmaceutical company, we are urgently looking for a Regional clinical site lead.
Do you have an MD degree?
Do you have experience practising medicine combined with experience in the pharmaceutical industry?
Are you fluent in Dutch and English, and do you have knowledge of French?
Then you are the ideal candidate for this role! Don't hesitate and apply as soon as you can!
Responsible for country site management and clinical/medical/scientific oversight for assigned studies:
Site Management & Delivery:
• 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.
• Provide recommendations on potential sites and provide targeted follow up with key sites as required. Influence the study teams in the selection of INSPIRE sites
• Oversee and support study start up activities at the country level, including review of key documents (e.g. 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 enrollment 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. Conducts risk assessments to identify actions for mitigation and control across studies.
• Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control. Demonstrates use of this data to enhance quality and accelerate study delivery.
• Conduct and report oversight activities, both remote and onsite visits according to company standards.
• Proactively identify, manage and escalate site issues.
• Help to address Significant Quality Events or other quality issues at patient and/or site level.
• Ensure resolution of investigator site issues in order to maintain sound investigator relations.
• Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion.
• Provide support for site audits/inspections as needed.
• Maintain a thorough knowledge of assigned protocols.
• Demonstrate TA/Category expertise where appropriate.
• Colleagues with MD equivalent qualification and required experience will take on medical monitoring responsibilities, including participation in 24/7 medical cover, being the local point of contact for medical issues and assisting with complex safety, eligibility and other patient or protocol issues.
• Demonstrates the learning culture by ensuring preventive actions are shared across assets in the portfolio to drive accelerated drug delivery
• Systematically applies site level learnings from risk identification, mitigation and control, across the trial and beyond (e.g., on asset level)
• Drives continuous improvement initiatives and implementation within GCTE and across Clinical Sciences & Operations to ensure successful trial delivery
Study Team Interface:
• Interface with the study team as needed and act as representative of the RCSL function. Recognized historically as a critical contributor to the success of a study team.
• Champion and ensure update of existing tools / processes related to clinical site selection and management.
• As needed, facilitate the exchange of information to / from the study team on study progress and impact of local clinical development environment on study / site.
• Provide regional and cross-regional insights on study-site performance and trends to / from the study team.
• Represents RCSL organization on country level and/or acts as a delegate for the Director of Clinical Site Management.
- MD degree is required
- Minimum 1 year of experience practising medicine
- Previous experience in clinical research is required
- Fluency in English and Dutch is required, knowledge of French is an asset
015 21 11 04