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 DescriptionAt 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 Senior Manager, Study Site Engagement is the local face of Takeda by contributing to an effectivepartnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e.,the Clinical Research Associate (CRA)/Monitor). The Senior Manager, Study Site Engagement establishescommunication with regional/country Associate Director, Study Site Engagement, and Medical Affairs (MA),provides updates on study/site status, and establishes site engagement study specific strategies.The Senior Manager, Study Site Engagement supports study teams with trial operations from Feasibilitythrough Clinical Study Report (CSR) within the assigned region or countries across Takeda therapeuticareas.The Senior Manager, Study Site Engagement enhances engagement and offers added value by providingguidance and sharing knowledge with study sites, while establishing and nurturing long-term relationshipswith investigators and study site personnel. The Senior Manager, Study Site Engagement supports countryand site identification, feasibility, site selection, study start-up, study recruitment strategies, and mitigatesbarriers at the direction of Clinical Programs.The Senior Manager, Study Site Engagement supports Takeda study teams as part of their day-to-dayresponsibilities and may act as an SSE-Study Lead (SSE-SL)ACCOUNTABILITIES:  Study Specific Engagement ActivitiesEarly engagement - Country and Site FeasibilitySupports 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-SLLiaises 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 InitiationSupports 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 PhaseSupports recruitment strategy and activities when targets are not met (e.g. utilization of Patient Recruitment & Retention 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.TrainingApplicable local regulationsSOP trainings (Takeda and CRO, as applicable)TA/Study specific trainingSenior Manager, Study Site Engagement is expected to comply with internal guidelines and utilize company-provided tools, for applicable tasks and reporting.Non-Study Specific Engagement activitiesParticipation in following activities may vary depending on assignment by Line ManagerSSE 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 RelationshipsThe 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 documentCORE ELEMENTS RELATED TO THIS ROLE: Technical/Functional (Line) ExpertiseUnderstanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicableglobal and regional/country requirements.Decision-making and AutonomyAble to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Takeda from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.InteractionThe Senior Manager, Study Site Engagement regularly interacts with internal and external stakeholders. Key stakeholders for this role include but are not limited to Takeda Clinical Operations, Takeda Clinical Study Start-up and Engagement (CSSE) functions, Takeda Clinical Science, Takeda Medical Affairs, local R&D functions, site and CRO personnel.InnovationFoster enhanced site engagement by executing the global engagement strategy. Utilize innovative thinking to overcome obstacles and achieve goals.ComplexityPossesses inter-cultural competencies and ability to work cross-functionally in a complex global organization. Additional details are included in the SSE Program Lead and SSE Study Lead guidance documentEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: EducationBachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (BSN, MS, MA, MBA, PharmD) is preferred.Experience7+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. Experience may also include roles such as Study Coordinator or Study Nurse, where close collaboration with Clinical Research Associates was involved. While experience in a Lead CRA or managerial role is preferred, it is not mandatory. The total cumulative work experience of the candidate may also be taken into consideration.Essential QualificationsExtensive site management and/or monitoring experience across a range of highly complex disease areasDemonstrated capability of effective site oversightSolid knowledge of clinical development processes with strong emphasis on site managementAbility to lead, troubleshoot and influence for quality and deliveryProven experience in effectively communicating with site staff including KOLsExperience in all study phases and in multiple indications preferredComprehensive and current regulatory knowledge, including GCPsAdditional SkillsGood organizational skills and ability to deal with competing prioritiesEffective communication skills (written, verbal in English and local language)Creative thinker, curious and unafraid to ask questionsInnovator, willing to initiate changes, introduce new ideas, and creatively problem solveProficient with MS Office Suite (Excel, Word and PowerPoint).Additional Information· Demonstrates flexibility in schedule and willingness to travel frequently (at least 30% and as high as 50% during busy periods).LocationsLodz, PolandBase Salary Range:zł313,200 - zł430,650.00For information about our benefits, please click here.LocationsPOL - Poland RemoteWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote