FSP Site Engagement Manager (Shanghai)

• Reports directly to the FSP CRO Line Manager.
• Receives study-specific requests and operational guidance from the Site Engagement Leads, Head of Site Engagement and Clinical Project Manager.
• Serve as the “face” of the to develop/strengthen relationships with new/current clinical trial investigators and their research site staff to facilitate recruitment and retention of subjects in clinical trials on behalf of the Sponsor.
• Enhance clinical trial investigators’ and their research staff’s awareness of and relationship with the company (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.)
• Function in accordance with the Company Code of Conduct, Standard Operating Procedures (SOPs)/Working Practices (WPs), and local/country regulations. The SEM may also contribute to the development and implementation of new SOPs/WPs as applicable.
• Be assigned up to approximately 20-25 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 company clinical trials.
• Serve as company primary point of contact between the organization and site personnel, while fostering a sense of partnership and mutual benefit to enhance long-term relationships with investigators and site staff.
• Have repeated interactions with clinical trial investigators and their research staff over the course of each trial to ensure that the trial remains on their “top of mind” – (Interaction E.g., on-site visits, virtual meetings, phone contacts, email, webinars, etc.)
• 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.
• Develop tailored engagement plans and strategies for each investigator site to align with their specific needs and challenges.
• In case is need during the course of the study (e.g. critical escalations) collaborate with 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.
• 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.
• Analyse patient enrolment and retention methods to identify potential roadblocks and propose strategies to increase patient recruitment and/or retention rates at each site.
• Identify potential risks associated with site performance and escalate issues as needed to mitigate any negative impact on trial timelines and outcomes.
• Escalate accordingly any concerns with regards to compliance, regulations, and quality standards to support sites’ adherence to study requirements.
• 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.
• Regularly assess the effectiveness of site engagement strategies and make recommendations for improvements based on industry best practices and lessons learned.
• Collaborate with cross-functional teams to ensure alignment of goals.
• Conduct/participate in site feasibility assessments/qualification visits (as applicable) and participate in Pre-Selection Visits (PSVs) and Site Initiation Visits (SIVs) 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.
• Actively participate in Investigator meetings as required.
• 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.
• Participate actively in SE initiatives (roundtables, etc)
• Receives access to the appropriate electronic systems, with the exception of the ones restricted to employees (e.g. SAP, Dikesi)

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