Associate Director, Site Start Up and Maintenance

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 work towards 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 a necessary contributor to our inspiring, bold mission.

GOALS:

• 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 external study team 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 site maintenance services.

ACCOUNTABILITIES:

• Responsible for line management, mentoring, and development of assigned staff
• Accountable for defining, developing, and delivery of site maintenance 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 Site Start Up 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 AND EXPERIENCE:

• BS degree or international equivalent in a life science required, advanced degree preferred.
• 8 or more years of experience 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 vendor required.
• 5 or more years of direct responsibility in site management and oversight of the site maintenance processes of clinical research studies at a sponsor or CRO.
• Direct experience in the pharmaceutical industry or related field required.
• Expertise in clinical trial regulations and ethics committee submissions.
• Expertise in site contract and budget amendments administration.
• Expertise with leading edge trial optimization vendors, tools, and methods.
• Experience in line management and working in a matrix environment.
• Proficiency with software models and database structures.
• Expertise in principles driving site maintenance strategies including site contract amendments.
• Ability to strongly demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery.
• Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team.
• Ability to explain data, facilitate decision making processes to be data driven.