Site Engagement Lead

The purpose of the Site Engagement Lead (SEL) is to oversee and manage the operational activities of Site Engagement Managers (SEMs). This role involves supporting the Head of Site Engagement in driving initiatives to ensure that proper procedures, training plans, and systems are in place. The SEL is responsible for developing fit-for-purpose solutions in close collaboration with Clinical Project Managers (CPMs) to enhance positive relationships with Principal Investigators (PIs) and site staff, thereby accelerating study timelines. Additionally, the role ensures that all operational activities performed by SEMs meet expected metrics in terms of quality and timelines, aligning with the company's objectives and vision. If appointed, the SEL will coordinate SE unit operations and objectives with Clinical Operations (Clin Ops), overseeing the correct implementation of information flow and making necessary adjustments.

• Management of resources:
  
  
  
  • collaborate effectively with all Site Engagement team members to ensure a positive dynamic.
  • provide inputs to and agree with Head of SE on SEMs assignment to studies and sites, based on sites engagement strategy including site handover oversight.
  • contribute to establish annual goals of SEMs and to the SEMs performance assessment.
  • work with Head of SE in the set-up of KPI and milestones for SEMs.
  • weekly review activities and needs assessments with SEMs.
  • review of SEM interactions' reports and planning of the interactions, ensuring contents/planning are adequate/in line with study needs, and issues were escalated properly.
  • periodic review of KPIs, monitor study progress, and report the findings to Head of SE for further discussion.
  • collaborate with SEMs to develop, build and maintain relationships with investigators/staff to ensure continued performance.
  • support in providing adequate training to SEMs.
  • support team needs and promote best practice sharing between the Site Engagement team members.
  
  
  
  
• Contribute to creating and maintaining an environment that welcomes diversity and ensures a respectful and secure working atmosphere where innovation is actively embraced and encouraged.
• Escalate promptly to study team questions/concerns raised by SEMs or identified autonomously, to facilitate smooth trial execution and to provide crucial sources of intelligence for study teams.
• Identify potential clinical trial investigators who are new to the Sponsor through a variety of sources as: prior experience w/Investigators, literature reviews, scientific/medical conf., etc.
• Drive Site Engagement Unit recruitment initiatives (e.g. roundtables, peer-to-peer meetings, mentoring programs).
• Collaboration:
  
  
  
  • transversal, direct collaboration with CPMs and Disease Area Leads, with regards to studies start up and site issues for clinical projects.
  • support the Global Clinical Development / Global Clinical Operations in expediting operational activities.
  • collaborate with external service providers and third-party vendors to ensure alignment with trial execution goals, and efficiency in trial execution, from feasibility to database lock.
  
  
  
  
• Networking: build and maintain relationship with networks aimed to develop and strengthen the Chiesi positioning in the Scientific Community.
• Actively attend Investigators Meetings and present if required.
• Collect, capitalization of a site expertise, assessing data analytics to produce meaningful recommendations to enhance the study success.
• Quality / Excellence:
  
  
  
  • follow the successful implementation of the remediation plan and/or critical issue raised by SEMs on clinical sites.
  • implement best practices and consistency of standards (including SOPs) for study and program management in collaboration with other members of the clinical operations team.
  
  
  
  
• Act as SEM, if needed.
• Other duties may be performed as assigned

• At least 5-7 years of proven experience in site engagement, as well as clinical trial management, study site coordination, or related roles within the pharmaceutical, biotechnology, or CRO industry.
• At least 2 years of proven experience in line management.
• Understanding of healthcare compliance and other relevant guidance.
• Understanding of the clinical trials settings and recruitment matter.
• Ability to work in international, multi-cultural context, as the position requires contacts and travels to other Countries.
• Strong understanding of clinical trial operations, regulations, and Good Clinical Practice (GCP) guidelines.
• Excellent communication, negotiation, and interpersonal skills.
• Line Management.
• Problem-solving mindset with the ability to navigate complex challenges.
• Detail-oriented with strong organizational and time management skills.
• Ability to build and maintain relationships with diverse stakeholders.
• Proficiency in relevant software and tools used for data tracking and communication.
• Flexibility to adapt to changing priorities and evolving project needs.

Bachelor's degree or equivalent in appropriate scientific disciplines, Master's Degree and/or MBA, familiar with relevant ICH/GCP, EU and FDA guidelines and SOPs.