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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 :

• The Associate Director, Site Start Up and Maintenance is responsible for line management of assigned staff, as well as defining, developing, and delivery of the global site regulatory and site budgeting and contracting maintenance tasks , by partnering with internal and ex ternal s tudy t eam members .

• Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to effectively conduct accurate and effective resourcing forecasts, robust planning , and on time delivery of site maintenance tasks .

• Directly support priority or highly complex projects through study closure.

• Champion the creation and implementation of innovative processes , methodologies , data and technologies that will ensure ongoing delivery of valued site startup and s ite m aintenance s ervices.

Accountabilities :

• Responsible for line management, mentoring, and development of assigned staff

• Accountable for defining, developing, and delivery of s ite m aintenance tasks

• Partners with CRO's, Clinical Operations teams, and TAU partners to improve overall metrics and implement processes

• Provides guidance, oversight, and training to the S ite Start U p and Maintenance Teams , delivering activities in support of Clinical Programs, including data and methodologies for efficient and effective site maintenance planning, and modeling

• Ensures consistent standards are applied to the site maintenance process 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 accelerate site maintenance timelines

• Leverages leading industry tools and data sources to provide data on timelines and performance to assist study teams with study site maintenance timeline forecasting

• Agrees to deliverables on a country and site-level basis with the study team and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.

• Leads the cross-functional site maintenance team, utilizing the appropriate team members to support the study site maintenance requirements

• Serves as point of escalation and assists in 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 contracting and / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry 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 a matrix environment

• Proficiencywith software models and database structures

• Expertisein principles driving site maintenance strategies including 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

LocationsZurich, Switzerland

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time