• Job Description

  Req#: R0097136

  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

  Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
  
  As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D (Research & Development) headquarters.

  Clinical Quality Management (CQM) at Takeda

  Clinical Quality Management is responsible for implementing an enterprise-wide strategy for Risk Based Quality Management (RBQM) and Adaptive Monitoring (AM) to focus on critical-to-quality risks that drive data quality and site performance across the entire study lifecycle.

  OBJECTIVE S :

  This position reports to a D irector of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.

  ACCOUNTABILITIES :

  • R esponsible for the implementation of RBQM procedur es for assigned studies

  • Reviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, and meaningful key risk indicators including quality tolerance limits in collaboration with the study team

  • Develop s study specific content and lead s RBQM training and RBQM kick-off meetings

  • Author s and implement s the study specific RBQM plan

  • Lead s risk assessment meetings , engaging cross-functional study team members to identify Critical-to-Quality ( CtQ ) risks throughout the trial lifecycle

  • Partner s with the RBQM system configuration team to ensure risk indicators , quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system

  • Perform s periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leverag ing availabl e analytics/visualizations in the RBQM syste m to identify emerging risks and/or issues

  • Lead s risk review meetings and discussions with study team members to effectively communicate and discuss the findings , facilitate s and encourages robust root cause identification and mitigation strategies

  • E nsure s corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/ or impacted functions

  • Monitor s the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as needed

  • Create s signal and trending reports for study teams to support their interpretation of RBQM output

  • Partner s with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data review

  • Maintains up-to-date, accurate documentation of RBQM activities

  • Support s and p articipate s in internal and external audits and inspections

  • Maintain s high quality, consistency, and compliance with RBQM procedures across studies

  • Adjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measures

  • Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes

  • Act s as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit

  • Support s inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework

  • May perform line management of other (junior) staff within RBQM Operations

  EDUCATION, EXPERIENCE , KNOWLEDGE, AND SKILLS:

  Education: Bachelor’s D egree in a health-related, life science area o r international equivalent preferred, or equivalent combination of education, training, and work experience

  Experience:

  • Minimum of 6 years of experience in the pharmaceutical or CRO industry

  • Minimum of 2 years of experience in Risk Based Quality M anagement

  • Minimum of 2 years of managerial and supervisory experience

  • Robust understanding of the drug development process and clinical trial execution

  • Knowledge of industry regulator y standards including 21 CFR Part 11, ICH E6 , ICH E8 (GCP)

  TRAVEL REQUIREMENTS:

  • Requires 0 - 10 % travel, potentially including overnight and international travel

  Base Salary Range: $130,200 Range Min to $186,000 Range Mid. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.

  The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

  “This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.”

  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

  North Carolina - Virtual

  Worker Type

  Employee

  Worker Sub-Type

  Regular

  Time Type

  Full time

• About the company

  Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

Notice