Job Description
The Site Engagement Manager
Location: Italy
About the company: An international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
The Site Engagement Manager (SEM) will:
Serve as the "face" of the Sponsor to develop/strengthen relationships with clinical trial investigators and their research site staff to facilitate recruitment and retention of subjects in pharmaceutical/biopharmaceutical industry clinical trials. Contribute to enhancing clinical trial investigators' and their research staff's awareness of and relationship with the Sponsor through direct interactions and other mechanisms. Be assigned up to approximately 20 investigator sites on average and may be assigned to more than one trial at a given time. Have repeated interactions with clinical trial investigators and their research staff over the course of each trial. Collaborate with clinical research associates/assistants (CRAs) and the study team to ensure that investigators and their site staff have a thorough understanding of the investigational agents being used in the trial. Understand how the trial fits into the site's pattern of treatment for the condition. Serve as a liaison with key investigators to help ensure that they receive prompt assistance with any queries. Develop and nurture positive and collaborative relationships with clinical trial sites. Monitor and analyze patient enrollment and retention methods. Proactively identify and escalate any operational, logistical, or performance-related issues. Maintain clear and consistent communication channels with site coordinators, investigators, and staff. Assess site performance with trial protocols and escalate concerns as needed. Develop tailored engagement plans and strategies for each investigator site. Relay any necessary trainings needed by site personnel on trial protocols. Collaborate with data management teams to reinforce accurate and timely collection and reporting of trial-related data. Regularly assess the effectiveness of site engagement strategies. Define, monitor, and report Key Performance Indicators (KPIs) relative to site engagement. Identify potential risks associated with site performance and escalate issues as needed. Collaborate with other departments and external service providers to ensure alignment of goals. Identify potential clinical trial investigators new to the Sponsor. Conduct/participate in site feasibility assessments/qualification visits. Contribute to building strong collaborations between the Sponsor and various advocacy groups. Qualifications:
Bachelor's degree in a related field; advanced degree preferred. Proven experience in site engagement, clinical trial management, or related roles (at least 3-5 years' experience). Strong understanding of clinical trial operations, regulations, and Good Clinical Practice (GCP) guidelines. Excellent communication, negotiation, and interpersonal skills. 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. #LI-OG1#J-18808-Ljbffr