Clinical Trial Associate

Company: Takeda Pharmaceutical
Location: Highland Park
Posted on: May 8, 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 and . 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 a Clinical Trial Associate based in Cambridge, MA or remotely reporting to the Clinical Trial Associate Manager.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, encourage innovation, 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 an important contributor to our inspiring, bold mission.GOALS:The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

• Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
• Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks.
• Perform developmental tasks with oversight of CTA Manager.ACCOUNTABILITIES:For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
  • Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
  • Support oversight of risk-based monitoring.
  • Attend important team meetings.
  • Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
  • Support additional ad-hoc activities, as agreed with CTA Manager.
  • Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
  • Escalate clinical trial insurance issues.
  • Support Health Care Provider Engagement for facilitating contracts and meetings.
  • Support vendor contract administration.EDUCATION AND EXPERIENCE:
    • Bachelor's degree or equivalent international degree.
    • 1 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
    • Experience in Phase 2 and 3 studies and global/international studies is advantageous.
    • Experience working across multiple therapeutic areas is advantageous.
    • Knowledge in global regulatory and compliance requirements for clinical research.
    • Excellence in task management and collaboration.TRAVEL REQUIREMENTS:
      • Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan
        • Tuition reimbursement Company match of charitable contributions
        • Health & Wellness programs including onsite flu shots and health screenings
        • Generous time off for vacation and the option to purchase additional vacation days
        • Community Outreach ProgramsLocation and Salary Information:
          • Location(s): Cambridge, MA or remote.
          • Base Salary Range: $60K-85K based on candidate professional experience level.This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.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 - VirtualLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Elizabeth , Clinical Trial Associate, Healthcare , Highland Park, New Jersey