Associate Director, Site Start Up and Maintenance
応募 後で応募 求人ID R0164033 掲載日 09/30/2025 Location:Zurich, SwitzerlandBy 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 Noticeand 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
The Associate Director, Site Start-Up and Maintenance plays a pivotal leadership role within the global clinical operations team. This position is responsible for overseeing the strategic planning and execution of global site regulatory, budgeting, and contracting maintenance activities. The role ensures the delivery of high-quality, timely site maintenance services by collaborating closely with internal and external stakeholders.
Objective / Purpose:
TheAssociate Director, Site Start Up and Maintenanceis responsible forline management of assigned staff, as well as defining, developing, and delivery of the global siteregulatoryand site budgeting and contracting maintenancetasks,by partnering withinternal and externalstudyteammembers.
Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to effectively conductaccurateand effectiveresourcingforecasts, robustplanning, andon time delivery ofsitemaintenance tasks.
Directly support priority orhighly complexprojects through study closure.
Champion thecreationandimplementationof innovativeprocesses,methodologies, data andtechnologiesthatwillensureongoingdelivery ofvaluedsite startup and sitemaintenanceservices.
Accountabilities:
Responsible for line management, mentoring, and development of assigned staff
Accountable for defining, developing, and delivery ofsitemaintenance tasks
Partners with CRO's, Clinical Operations teams, and TAU partners to improve overall metrics and implement processes
Provides guidance, oversight, and training to theSiteStartUpand Maintenance Teams, delivering activities in support of Clinical Programs, including data and methodologies forefficient and effectivesite maintenanceplanning, and modeling
Ensures consistent standards are applied to thesite maintenanceprocess across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches
Drives the creation and implementation of innovative solutions to improve processes and acceleratesite maintenancetimelines
Leverages leading industry tools and data sources to provide data on timelines and performance toassiststudyteams with studysitemaintenancetimeline forecasting
Agrees to deliverables on a country and site-level basis with thestudy teamandmonitoradherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
Leads the cross-functional sitemaintenanceteam,utilizingtheappropriate teammembers to support thestudysite maintenancerequirements
Serves as point of escalation andassistsin resolution of issues
Act as a role model for Takeda’s values
Education & Competencies:
BS degree or international equivalent in a life sciencerequired, advanced degree preferred
Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up,site budgeting and contractingand / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO orrelevantindustry vendorrequired
More than 5 years of direct responsibility in site management and oversight of the site maintenanceprocesses of clinical research studies at a sponsor or CRO
Expertisein clinical trial regulations and ethics committee submissions
Expertisein site contract and budgetamendments administration
Expertisewith leading edge trial optimization vendors, tools, and methods
Experience in line management and workingin amatrixenvironment
Proficiencywith software models and database structures
Expertiseinprinciplesdriving sitemaintenancestrategiesincluding site contract amendments
Direct experience in the pharmaceutical industry or related fieldrequired
Ability to stronglydemonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operationaldelivery
Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop,collaborateand lead within a global matrixed team
Ability to explain data,facilitatedecision making processes to be data driven