Manager, Site Start Up

Takeda

3d • Remote

About The Position

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Site Start Up based remotely reporting to the Associate Director, Site Start Up. 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 site start up manager defines developing and delivery of the global site start up plan. Oversee the analysis of clinical trial data and its application to conduct accurate study start up forecasts. Drive rapid, accurate, and data-driven study start up forecasts, benchmarking assumptions, scenarios and accurate planning. Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Site Start Up Services. ACCOUNTABILITIES: Establish, develop, and deliver the Global Site Start Up Plan. Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes. Provide guidance, oversight, and training to the Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling. Ensure standards are applied to the study start up process across project portfolios and support continuous improvement activities while developing TA-aligned strategies. Guide the collection and analysis of all data to influence site start up timelines. Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting. Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these. Promptly recognize and improve potential delays, and escalate non-performance. Lead the site start up team, using the appropriate team members to help implement the Site Start Up Plan. Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll". Resolve escalated issues identified by the site start up team in partnership with the Study Manager.

Requirements

• BS degree or international equivalent in a life science.
• 4 or more years of experience in Clinical Operations, Project Management, study start up, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
• 2 or more years of direct responsibility in site activation and managing the study start up processes of clinical research studies at a sponsor or CRO.
• Proficiency with software models and database structures.
• Ability to explain data, facilitate decision making processes to be data driven.
• Expertise in principles driving country/site start up and study start up strategies.

Nice To Haves

• Global SSU experience preferred.

Responsibilities

• Establish, develop, and deliver the Global Site Start Up Plan.
• Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes.
• Provide guidance, oversight, and training to the Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start up, country and site selection, study start up planning, and modeling.
• Ensure standards are applied to the study start up process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
• Guide the collection and analysis of all data to influence site start up timelines.
• Leverage leading industry tools and data sources to provide data on start up timelines and performance (data quality, start up cycle time) to assist project teams with site initiation timeline forecasting.
• Agree to deliverables on a site-level basis with the SSU team and monitor adherence to these.
• Promptly recognize and improve potential delays, and escalate non-performance.
• Lead the site start up team, using the appropriate team members to help implement the Site Start Up Plan.
• Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll".
• Resolve escalated issues identified by the site start up team in partnership with the Study Manager.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees