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Lead Clinical Trial Associate (Remote)

Company: Takeda Pharmaceuticals
Location: Sacramento
Posted on: September 23, 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 Takedas 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 a Lead Clinical Trial Associate based in Cambridge, MA, Lexington, 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 Lead Clinical Trial Associate (CTA) will independently perform tasks related to supporting operational strategy of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

  • Provide support for essential daily clinical study activities, following established protocols under the general guidance of the Clinical Trial Associate Manager.
  • Provide oversight of deliverables and lead Clinical Trial Associate team during regulatory inspections and develop strategies for regulatory inspections.
  • 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.
  • Provide leadership to the Clinical Trial Associate team and study teams for more complex studies.
  • Perform departmental tasks, including being a lead on processes; make presentations to Clinical Operations; act as mentor to junior Clinical Trial Associate team members.
  • Perform developmental tasks with oversight of the Clinical Trial Associate Manager.A CCOUNABILITIES:
    • Support more complex programs and studies to build best clinical trial support strategies.
    • Approval of study documentation, including essential document packets, study plans, informed consent forms.
    • Support oversight of risk-based monitoring.
    • Attendance of essential team meetings ; may make presentations (e.g. data, resourcing, projects).
    • Make presentations to senior leadership of therapeutic areas and R&D departments.
    • Support regulatory inspection readiness (e.g. preparation of materials, oversee deliverables, and lead Clinical Trial Associate team during regulatory inspections and develop strategies for regulatory inspections.)
    • Support additional ad-hoc activities, as agreed with the Clinical Trial Associate 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.
    • Maintain knowledge and acts as team super-user for related systems; provide presentations, training, and support to Clinical Trial Associate team; provide updates to applicable Clinical Trial Associate resources.
    • May make presentations to Clinical Operations.
    • Lead functional working groups.
    • Help with special projects.
    • Mentor to junior Clinical Trial Associate team members.
    • Support new Clinical Trial Associate team member onboarding.
    • Provide expertise in complex startup activities and operating model to study teams.
    • Understand GCP, ICH, and applicable regulatory standards governing clinical research.EDUCATION AND EXPERIENCE:
      • Bachelor's degree or equivalent international degree.
      • 4+ 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.Additional Information
        • Up to 10% domestic and international travel, including in-person attendance at designated Takeda offices based on business needWHAT 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): Remote
            • In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
            • Base Salary Range: $79,000 to $114,000, 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 Colorados Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq.
            • This position is currently classified as remote in accordance with Takedas Hybrid and Remote Work policy.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 - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote

Keywords: Takeda Pharmaceuticals, Sacramento , Lead Clinical Trial Associate (Remote), Healthcare , Sacramento, California

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