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Site Engagement Specialist I

hace 3 meses

Alcobendas, Madrid, España Parexel A tiempo completo

When our values align, there's no limit to what we can achieve.

Job Purpose:

The Site Engagement Specialist I (SES I) serves as the primary representative for our clients, ensuring that investigative sites receive essential support and engagement throughout the study lifecycle. This role is crucial for maintaining the client's reputation and facilitating effective communication with sites. The SES I is responsible for overseeing site initiation activities, fostering relationships with investigators, and ensuring operational success at the site level while prioritizing quality and patient safety.

Key Responsibilities:

  • Contributes insights into site recommendations based on a comprehensive understanding of regional performance metrics and site capabilities.
  • Assists the Study Operations Manager in defining local requirements for the management of investigational products and supplies.
  • Implements global strategies for site and study operations by qualifying and activating designated sites.
  • Aids in optimizing site selection processes, including the evaluation of potential sites and providing outputs for site selection assessments.
  • Collaborates with stakeholders to provide regional input on feasibility surveys, including local medical practices and standards of care.
  • Maintains in-depth knowledge of assigned study protocols.
  • Executes study initiation activities at the site level, including the coordination of activation checklists and finalizing necessary documentation.
  • Ensures comprehensive training and documentation collection as per site activation requirements.
  • Supports the review and deployment of informed consent documents as needed.
  • Follows up on site readiness activities to ensure preparedness for the first subject visit.
  • Partners with site monitors to guarantee readiness for monitoring activities.
  • Cultivates strong relationships with investigative sites and oversees operational activities.
  • Provides support for escalated site issues, coordinating communication and resolution efforts.
  • Ensures adherence to strategies for investigational products and supplies throughout the study lifecycle.
  • Responsible for effective site recruitment planning and delivery, aligned with global and local targets.
  • Maintains regular communication with investigator sites to track progress and support recruitment efforts.
  • Collaborates with local regulatory authorities to ensure timely completion of necessary registrations.
  • Acts as the operational contact for site-level inquiries, facilitating resolution through appropriate channels.
  • Reviews site monitoring reports to ensure compliance and quality.
  • Assists sites with the revision and submission of informed consent documents.
  • Works collaboratively with other roles to maintain system management at the site level.
  • Conducts annual assessments of site management organizations to ensure continuity and address significant changes.
  • Monitors site practices to ensure alignment with client standards and regulatory requirements.
  • Maintains open communication with investigator sites to gather performance metrics and feedback.
  • Oversees site deliverables to ensure alignment with study targets.
  • Proactively identifies risks to quality and compliance, implementing mitigation strategies as necessary.
  • Supports the development of decentralized capabilities at investigator sites.
  • Ensures quality and consistency in monitoring delivery.
  • Drives efficiencies and best practices for study operations.
  • Contributes to shaping the local clinical development environment to enhance client reputation.
  • May serve as a Subject Matter Expert on client systems and processes.
  • Actively seeks efficiencies and best practices to improve site performance and satisfaction.
  • Maintains clear communication with the Study Operations Manager.
  • Supports site monitors in building positive relationships with investigators throughout the study.
  • Coordinates with various roles to optimize communication and enhance visibility into site activities.
  • Utilizes data analytics to identify risks and develop mitigation plans for site quality and compliance.

Skills:

  • Strong communication skills for effective interaction with stakeholders.
  • Adaptability to evolving technologies and processes.
  • Proficient verbal and written communication skills.
  • Proven networking and relationship-building abilities.
  • Experience in managing cross-functional relationships.
  • Capability to overcome barriers in implementing new processes.
  • Ability to establish effective relationships with site staff and stakeholders.
  • Proficiency in local language preferred; English required.

Knowledge and Experience:

  • Demonstrated experience in site management, including prior monitoring experience.
  • Familiarity with startup activities through to site activation.
  • Knowledge of quality and regulatory requirements in relevant countries.
  • Understanding of Good Clinical Practice (GCP) and ICH Guidelines.
  • Proficient computer skills and ability to embrace new technologies.
  • Strong presentation and interpersonal skills.
  • Willingness to travel as required.

Education:

  • Bachelor's degree or Registered Nurse in a related field, or equivalent combination of education and experience (minimum of 5 years).