West Bridgewater, MA

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 DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Site Identification and Selection Specialist based in Cambridge, MA or remotely reporting to the Director, Feasibility.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be an important contributor to our inspiring, bold mission.GOALS:The Site ID & Selection Specialist will oversee and ensure the delivery of global (end-to-end) site identification and selection (strategy, plans, activities, timelines, and synthesis of site/investigator insights and presentation to study teams) at a program/study level. Allow study teams to conduct ongoing delivery within timelines that contribute to operational planning / decisions resulting in predictable delivery for achieving R&D goals:Oversee site and investigator identification and selection based on a data-driven study strategy to insure predictable study delivery.Oversee the analysis of clinical trial data and its application to identify sites in selected countries which complement study startup forecasts and study strategies.Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued site identification and selection processes.ACCOUNTABILITIES:Define, develop, and deliver global site recommendations for each assigned study.Understand and translate protocol requirements to develop the ideal site profile, in collaboration with main Leads, especially the Feasibility Lead/Director.Mine relevant databases, available literature resources to identify the best suited sites for the study and advocate for inclusion of strategic relationship sites with the project team.Lead or help develop the Site Profile and Protocol Specific Site Requirements and Site ID Questionnaire/ Feasibility Survey specific to each protocol.Partner with CRO's, Clinical Operations teams, and TAU partners to improve overall Site ID and Selection process.Lead the technical and operational Site ID aspects of global projects including tracking and weekly reporting of project deliverables to the Takeda study team and CRO.Attend project team meetings (OSR, SET, Feasibility, and Regulatory) to provide updates relevant to Site ID and Selection.Collaborate with Feasibility Lead/Director and Study Startup team members about the Site ID and Selection strategy, including review of data and methodologies for country and Site ID and Selection.Ensure standards are applied to the Site ID and Selection process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.Use Takeda and industry tools and data sources, including local medical teams to provide recommendations of sites and investigators.Agree to deliverables with the CRO and monitor adherence. Recognize and improve potential delays, and escalate non-performance.Guide delivery of selected sites to insure study milestones of First Site Active and First Subject In can be met.Manage the analysis and ranking of sites based on site feasibility data to determine the final site list, including back-up sites.Support Feasibility Lead/Director in final selection of sites in collaboration with other Study Team members and CRO study representatives.Ensure sites are notified of selection decision based on results of site level feasibility assessment.May lead Site Identification and Feasibility departmental programs and act as a representative on other work streams.May help develop and maintain the global investigator database and communication materials.EDUCATION AND EXPERIENCE:BS degree or international equivalent required, in a life science.At least 2 years of pharmaceutical industry (or similar) experience required.Direct responsibility in site identification, feasibility, or managing the study startup processes of clinical research studies at a sponsor or CRO.Expertise in principles driving country/site identification.Expertise with leading edge trial optimization vendors, tools, and methods.Demonstrate, interpret, explain, represent and lead unbiased data insights into clinical trials operational planning.Explain data, facilitate decision-making processes to be data-driven.Proficiency with software models, database structures, and Microsoft Office Suite applications.Direct experience in the pharmaceutical industry or related field required.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.Base Salary Range: $79,800 to $114,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote