Clinical Trial Associate
Company: Takeda Pharmaceutical
Location: Maywood
Posted on: May 13, 2022
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.
Job Description
Are 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 Programs
Location 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 Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
EEO Statement
Takeda 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.
Locations
Massachusetts - Virtual
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Clifton , Clinical Trial Associate, Healthcare , Maywood, New Jersey
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