Location: Germany, Nordics, Ukraine, Slovakia, Poland and Hungary
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 research, 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 on behalf of the Sponsor, in accordance with the Sponsor’s Code of Conduct, Standard Operating Procedures (SOPs)/Working Practices (WPs), and local/country regulations; the SEM will contribute to the development and implementation of new SOPs/WPs as applicable Contribute to enhancing clinical trial investigators’ and their research staff’s awareness of and relationship with the Sponsor (including highlighting publicly available information regarding the Sponsor’s mission, values, pipeline, etc.) through direct interactions with clinical trial investigators and their research staff as well as via other mechanisms (e.g., Sponsor’s website, social media, etc.) in accordance with the Sponsor’s SOPs/WPs and regulatory requirements/guidelines (as applicable) Be assigned up to approximately 20 investigator sites on average and may be assigned to more than one trial at a given time depending upon multiple factors, including the number of participating sites for each trial, the stage of the trial (e.g., recruitment period, conduct period, etc.), and if the assigned investigator is concurrently participating in more than one of the Sponsor’s trials – the intent is for one SEM to be assigned to each investigator site throughout the course of the trial for continuity as much as feasible. Have repeated interactions with clinical trial investigators and their research staff over the course of each trial to ensure that the trial remains “top of mind” with investigators and their research staff – these interactions will be conducted via a mixture of modalities, including on-site visits, virtual meetings, phone contacts, webinars, etc. 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, the trial’s eligibility criteria, and all trial procedures – particular attention will be given to assessing the effectiveness of each site’s strategy used to identify potentially eligible subjects. Understand how the trial fits into the site’s pattern of treatment for the condition and how any competing clinical trials or upcoming drug approvals may affect the progress of recruitment or conduct of the trial. Serve as a liaison with key investigators to help ensure that they receive prompt assistance with any queries and that any concerns they have are promptly transmitted to the trial’s Sponsor. Develop and nurture positive and collaborative relationships with clinical trial sites, serving as the Sponsor’s primary point of contact between the organization and site personnel. The CRA remains the site’s primary point of contact for all protocol and operational requirements. Monitor and analyze patient enrollment and retention methods to identify potential roadblocks and propose strategies to increase patient recruitment and/or retention rates at each site. Proactively identify and escalate any operational, logistical, or performance-related issues that may impact the sites' ability to execute the trial effectively. Collaborate with cross-functional teams to find timely solutions. Maintain clear and consistent communication channels with site coordinators, investigators, and staff. Provide regular updates on trial progress, garner feedback on suggested protocol modifications, and other relevant information. Assess site performance with trial protocols. Escalate accordingly any concerns with regards to compliance, regulations, and quality standards to support sites’ adherence to study requirements. Develop tailored engagement plan and strategies for each investigator site to align with their specific needs and challenges. Foster a sense of partnership and mutual benefit to enhance long-term relationships. Relay to the study team any necessary trainings needed by site personnel on trial protocols, data collection, and reporting procedures. Escalate any questions or concerns promptly to facilitate smooth trial execution. Collaborate with data management teams to reinforce accurate and timely collection and reporting of trial-related data from sites. Regularly assess the effectiveness of site engagement strategies and make recommendations for improvements based on industry best practices and lessons learned. Define (in conjunction with the Sponsor), monitor, and report to the Sponsor Key Performance Indicators (KPIs) relative to site engagement and make adjustments in site engagement strategies in response to the KPI data. Identify potential risks associated with site performance and escalate issues as needed to mitigate any negative impact on trial timelines and outcomes. Collaborate with other departments, including clinical operations, data management, regulatory affairs, and project management, and external service providers (including Clinical Research Organizations [CROs] and other third-party vendors [e.g., centralized spirometry, centralized electrocardiogram [ECG], clinical laboratories, data management, etc.]) to ensure alignment of goals and effective and efficient trial execution. Identify potential clinical trial investigators who are new to the Sponsor through a variety of sources, including prior experience with Investigators, literature reviews, scientific/medical conferences, internet searches, etc. Conduct/participate in site feasibility assessments/qualification visits (as appliable) and participate in site initiation visits with the CRAs to ensure the robustness of these assessments/visits and a thorough evaluation of the investigators’ and their clinical research staff’s capabilities to successfully conduct the trial according to the protocol and to achieve their subject recruitment and retention targets and share findings and recommendations with the Sponsor Contribute to building strong and effective collaborations between the Sponsor and Health Care Systems/Networks/Institutions and various advocacy groups, including disease-focused and patient-focused groups, to identify potential Investigators and research centers new to the Sponsor and enhance subject recruitment.
- Bachelor's degree in a related field; advanced degree preferred. Proven experience in site engagement, as well as clinical trial management, site management, study site coordination, or related roles within the pharmaceutical, biotechnology, or CRO industry (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.