Associate Director, Site Start Up and Maintenance

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.

• 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.

• 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

• 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, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time