Director, Testing & EDC Administration

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor’s Degree or international equivalent preferred, or equivalent combination of education, training and experience., 10 or more years experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in clinical study management., Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams., Strong strategic thinking, planning, execution, and communication skills..

Key responsabilities:

  • Responsible for the development and implementation of strategy to support testing, EDC administration and user access.
  • Drive collaboration with stakeholders to align on individual function testing and EDC administration responsibilities.
  • Develop processes, SOPs, and tools to support functional responsibilities.
  • Train, coach, and mentor supervised employees to create a culture that attracts, retains and develops critical thinkers.

Biolife Plasma Service logo
Biolife Plasma Service Large http://www.biolifeplasma.com
5001 - 10000 Employees
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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 Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Director, Testing & EDC Administration based remotely reporting to the Head, Testing, Innovation & Data Enablement.

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:

  • Functional owner responsible for the development and implementation of strategy to support testing, EDC administration and user access.
  • Innovative leader who incorporates novel methods and technologies to drive efficiencies.
  • Develop a team with capabilities for the planning, development, and execution of tailored testing methodologies for clinical trials.

ACCOUNTABILITIES:

  • Responsible for clinical trial testing and EDC administration approach across all data collection platforms, utilizing industry trends to establish a comprehensive methodology in both disciplines.
  • Ensure consistent and compliant application across computerized systems.
  • Establish a framework for standards and best practices to provide reliable solutions that align with quality and compliance requirements.
  • Create a mechanism for continuous improvement extracting lessons learned from CAPAs, audit findings and testing cycles.
  • Drive collaboration with stakeholders to align on individual function testing and EDC administration responsibilities.
  • Identify management and automation tools to reduce costs and improve quality while increasing effectiveness.
  • Serve as a strategic thought partner to the Head of Testing, Innovation, and Data Enablement, cross functional teams, and direct reports with respect to data strategy implementation.
  • Responsible for developing processes, SOPs, and tools to support functional responsibilities.
  • Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops critical thinkers.
  • Act as a role model for Takeda´s values.

EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree or international equivalent preferred, or equivalent combination of education, training and experience.
  • 10 or more years experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in clinical study management and at least 6 years of line management experience.
  • Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams.
  • Strong strategic thinking, planning, execution, and communication skills.
  • Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
  • Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. 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. 

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

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Strategic Thinking
  • Leadership
  • Business Acumen
  • Mentorship
  • Teamwork
  • Communication
  • Coaching

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