
Associate Director, Site Start Up and Maintenance
Zurich, Canton of Zurich- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal (if any)
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
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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
Locations
Zurich, SwitzerlandWorker Type
EmployeeWorker Sub-Type
RegularTime Type
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