Site Engagement Lead

**Date**:28 Apr 2025

**Department**:Global Clinical Development

**Business Area**:R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**:Direct Employee

**Contract Type**:Permanent

**Location**:Parma, IT

**Purpose**
- 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.

**Main Responsibilities**
- Management of resources:o collaborate effectively with all Site Engagement team members to ensure a positive dynamic.
- 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.
- Regularly assess the effectiveness of site engagement strategies and make recommendations for improvements based on industry best practices and lessons learned.
- As e-tools for SE become available, review regularly data analytics of study and sites milestone/metrics and discuss/report findings to Head of SE.
- Regularly access any study e-tools or trackers, to provide SEMs with up-to-date study/site specific information and monitor status in a holistic way.
- 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.
- work in synergy with other departments and units, to ensure SE Unit works organically and harmoniously in the broader Chiesi community.
- 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.
- ensure that engagement operations organization and infrastructure operates to expected clinical trial excellence standards.
- Act as SEM, if needed.

**Experience Required**
- 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.**Education**
- 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.

**Languages**
- English fluent**Technical Skills**
- Understanding of healthcare compliance and other relevant guidance.
Well 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.