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Associate Director, Study Start Up

Company: Takeda Pharmaceutical
Location: Weymouth
Posted on: November 21, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Study Start Up based in Cambridge, MA or remotely reporting to the Head of Site Startup.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 accomplish 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 deliver Better Health and a Brighter Future to people around the world.Here, you will be an important contributor to our inspiring, bold mission.GOALS:The Associate Director, Study Startup is responsible for line management of assigned Study Startup staff, and delivering of the global study startup project plan by partnering with the CRO on Study Startup:

  • Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to conduct accurate study startup forecasts, scenarios, and accurate planning.
  • Directly support priority or complex projects through the study startup process.
  • Promote the creation and implementation of creative processes, methodologies, data and technologies that will ensure ongoing delivery of valued Study Startup Services.ACCOUNTABILITIES:
    • Responsible for line management, mentoring, and development of assigned Study Startup staff.
    • Deliver the Global Study Startup Project Plan.
    • Partner with CRO's, Clinical Operations teams, and TAU partners to improve overall study startup metrics and implement processes.
    • Provide guidance, oversight, and training to the Study Startup team, creating activities to support Clinical Programs, including data and methodologies for protocol study startup, study startup planning, and modeling.
    • Ensure standards are applied to the study startup process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
    • Guide the creation and implementation of solutions to improve processes and accelerate study startup timelines.
    • Leverage leading industry tools and data sources to provide data on startup timelines and performance (data quality, startup cycle time) to assist project teams with study initiation timeline forecasting.
    • Agree to deliverables on a site-level basis with the CRO and monitor adherence to these.
    • Promptly recognize and fix potential delays, and escalate non-performance.
    • Lead the site activation team (internal and CRO) using the appropriate team members to help implement the Startup Project Plan.
    • Serve as point of escalation and help resolve issues identified by Takeda or CRO staff during the startup process.EDUCATION AND EXPERIENCE:
      • Bachelor's degree or international equivalent in a life science required, advanced degree preferred.
      • 8 or more years of experience in Clinical Operations, Project Management, study startup, or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required.
      • More than 5 years of direct responsibility in site management, activation and oversight of the study startup process of clinical research studies at a sponsor or CRO Experience in line management and working in a matrix environment.
      • Expertise with leading edge trial optimization vendors, tools, and methods.
      • Proficiency with software models and database structures.
      • Expertise in principles driving study startup and site startup strategies
      • Demonstrate, interpret, explain, represent, and lead unbiased data insights into clinical trials operational planningWHAT TAKEDA CAN OFFER YOU:
        • This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
        • In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
        • Base Salary Range: $180,000 - $200,000, based on candidate professional experience level.
        • Employees may also be eligible for Short Term and Long-Term Incentive benefits as well.
        • Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
        • This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

Keywords: Takeda Pharmaceutical, Weymouth , Associate Director, Study Start Up, Executive , Weymouth, Massachusetts

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