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Clinical Site Liaison I
Il y a 3 mois
Embracing our shared values unlocks limitless potential.
Parexel FSP presents a remarkable opportunity for a Clinical Site Liaison in France.
Position Overview:
The Clinical Site Liaison serves as the primary contact for investigative sites throughout the study lifecycle; responsible for site initiation activities through to activation; tasked with establishing and maintaining relationships with investigator sites while providing support from site selection through the entire study process; accountable for site-level recruitment and operational success, and ensuring the quality and safety of patients at the investigator site.
The Clinical Site Liaison plays a vital role in country and site selection efforts by actively collaborating with key stakeholders and supplying local insights for country outreach assessments, investigator strategies, and client pipeline opportunities under guidance.
As the representative of the client, the Clinical Site Liaison ensures that sites receive the necessary support and engagement, resolves issues, and upholds the client's reputation throughout the study lifecycle.
Furthermore, the Clinical Site Liaison will coordinate with various roles and functions that interact with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.), thereby enhancing communication and overall visibility into site-level activities.
Key Responsibilities:
- Implement site strategies by qualifying and activating assigned sites.
- Assist in optimizing country and site selection processes, including reviewing and assessing potential site lists and providing input for site selection.
- Collaborate with key stakeholders to provide regional insights for country outreach assessments, including protocol feasibility and local medical practices under supervision.
- Maintain comprehensive knowledge of assigned protocols.
- Conduct study initiation activities at the site level, including managing the site activation checklist, finalizing essential documents, and addressing any issues that may delay site activation.
- Ensure all site initiation activities are completed, including training and gathering necessary documentation for site activation.
- Support country-specific document reviews and deployments when necessary.
- Follow up on activities post-initiation to ensure site readiness for the first subject visit.
- Collaborate with site monitors to ensure readiness for monitoring activities.
- Foster relationships and oversee operational aspects of the site.
- Address escalated site issues related to study delivery by coordinating communication and resolution efforts.
- Ensure effective planning and delivery of site recruitment in alignment with global and local targets.
- Maintain regular communication with investigator sites to track progress and drive achievement of study goals.
- Partner with local regulatory and clinical teams to ensure timely completion of local registry requirements.
- Serve as the operational point of contact for all site-level inquiries, liaising with relevant teams to resolve questions.
- Review site monitoring reports.
- Assist sites with the revision and submission of essential documents.
- Manage system operations at the site level to ensure alignment across platforms.
- Review and update site assessments annually and as needed based on significant changes.
- Maintain communication with investigator sites to gather updates and performance metrics.
- Oversee site deliverables to meet study targets.
- Follow the study oversight plan and implement risk mitigation strategies.
- Support the development of decentralized capabilities at investigator sites.
- Ensure quality and consistency in monitoring delivery.
- Drive efficiencies and best practices for study operations.
- Contribute to enhancing the local clinical development environment to strengthen client reputation.
- May serve as a Subject Matter Expert on client systems and processes.
- Actively seek efficiencies and develop best practices to enhance site performance and satisfaction.
- Ensure clear communication with the Study Operations Manager.
- Support site monitors in building positive investigator relationships and address any compliance concerns.
- Provide insights into site recommendations based on a thorough understanding of local practices and performance metrics.
- Assist in defining local requirements for the import/export processes of investigational products.
Qualifications:
- Bachelor's degree in a scientific discipline.
- At least 5 years of independent monitoring experience.
- Oncology study experience is preferred but not mandatory.
- Proficiency in the local language is preferred; English is required.
