Senior Manager, Study Site Engagement

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are committed to transforming patient care through innovative clinical research and strong partnerships with the healthcare community. As a Senior Manager, Study Site Engagement , you will play a pivotal role in connecting Takeda study teams, clinical research sites, investigators, and CRO partners to ensure the successful delivery of our global clinical trials. This highly visible, field-facing role combines scientific understanding, operational expertise, and relationship-building to enhance site engagement across the full clinical trial lifecycle, from feasibility and site selection through study conduct and completion. You will serve as a trusted partner to investigators and site teams, helping to remove barriers, improve recruitment performance, and create an exceptional clinical trial experience that accelerates access to new therapies for patients worldwide. If you are passionate about clinical research, thrive in a collaborative global environment, and enjoy building meaningful relationships that drive study success, we'd love to hear from you. Why Takeda? At Takeda, our patients are at the centre of everything we do. You'll have the opportunity to work across diverse therapeutic areas, collaborate with talented colleagues around the world, and contribute to a culture that encourages innovation, continuous learning, and purpose-driven impact. Better Health, Brighter Future. Join us and help bring life-changing medicines to patients faster. OBJECTIVES/PURPOSE: The Sr. Manager, Study Site Engagement is the local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)). The Sr. Manager, Study Site Engagement establishes communication with regional/country Associate Director, Study Site Engagement, and the Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies. The Sr. Manager, Study Site Engagement supports study teams with trial operations from Feasibility through Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeutic areas. The Sr. Manager, Study Site Engagement enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. The Sr. Manager, Study Site Engagement supports country and site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs. The Sr. Manager, Study Site Engagement supports Takeda study teams as part of their day-to-day responsibilities and may act as a SSE-Study Lead (SSE-SL). ACCOUNTABILITIES: Study Specific Engagement activities Early engagement - Country and site feasibility Supports the Study Site Engagement Lead (SSEL)/ SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSEL/LOC support. Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team. Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL. Helps to follow up with country MA, local Clinical Operations team and keep track country and site selection activities. Study startup phase - Post site selection to site initiation Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned. Attends and/or supports SIVs. Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team. As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO. Enrollment and study conduct phase Supports recruitment strategy and activities when targets are not met (e.g. utilization of PR&R materials, booster visits, phone contacts). Interacts closely with local CRO team throughout the lifecycle of the study. Helps coordinate and/or attends the SSE booster visit requested by SSE-PL/SSE-SL. Regularly interacts with priority sites in assigned trials. Helps to maintain study specific trackers (booster visits) as needed or requested. Training: Applicable local regulations SOP trainings (Takeda and CRO, as applicable) TA/Study specific training Sr. Manager, SSE is expected to comply with internal guidelines and utilize company-provided tools, for applicable tasks and reporting. Non-Study Specific Engagement activities Participation in following activities may vary depending on assignment by Line Manager SSE Study Lead for assigned programs: Helps to develop the global Site Engagement Strategy for the assigned trial, adapting it as necessary to meet specific requirements of each country. Attends program and study level meetings, as applicable, and provides relevant updates to SSE team members. Attends kick-off meetings, investigator meetings (in region) Development of Strategic Site Relationships The Sr. Manager, Study Site Engagement, may be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks to improve the site and Takeda experience. Conferences, Congresses, Other Site Facing Events: The Sr. Manager, Study Site Engagement may be tasked to help the Associate Director, Study Site Engagement with developing and executing the SSE strategy for non-study specific activities within their designated Therapeutic Area (TA) or Country. Through participation in conferences or congresses, the Sr. Manager, Study Site Engagement utilizes these key site-facing events to connect with sites beyond their physical locations. This role involves engaging with new clinical trial investigators or those unfamiliar with Takeda, thereby promoting support for the advancement of our pipeline. Additional details are included in the SSE Program Lead and SSE Study Lead guidance document CORE ELEMENTS RELATED TO THIS ROLE: Technical/Functional (Line) Expertise Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements. Leadership SSE-SL role: Project management, I