• Job Description

  Req#: R0095747

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  Job Description

  Takeda

  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 :

  As the Sr. Mgr. Risk Based Quality Management - Adaptive Monitoring Excellence, you will report to the D irector of Adaptive Monitoring Excellence and are responsible for successfully developing and overseeing RBQM -appropriate monitoring strategies at the study level, driving the adoption of risk-based monitoring and data-driven monitoring solutions.

  Responsibilities:

  • A s assigned to support study execution team s , responsible for the implementation of Adaptive Monitoring procedur es

  • I nterpret critical data, critical processes, and key risk s assigned for site monitoring mitigations to determine study specific site monitoring requirements

  • Lead adaptive monitoring strategy meetings, engaging cross-functional study team members to identify study-level SDV and SDR strategies, aligned with Takeda’s adaptive monitoring schemas

  • Ensure risk-based monitoring strategies are integrated in Takeda’s IQRMP and site monitoring functional plan s , and ensures strategies are correctly configured in technology solutions (TSDV, Veeva CDMS, CTMS etc )

  • Partner with RBQM Operations team to e nsure central monitoring findings and other signals identified for site monitoring mitigation are effectively communicate d and addressed by site monitoring teams , documenting any need for the adjustment of source data verification or source data review targets

  • Perform periodic assessment of the compliance with monitoring plans at the study, region, site, monitoring partner and personnel levels, and identifies and escalates issues and emerging monitoring compliance risks to the study execution team

  • Leverage identified signals to c oordinate Monitoring Oversight Visit activitie s for selected studies, and ensures appropriate processing of related visit reports and findings

  • Maintain up-to-date, accurate documentation of Adaptive Monitoring activities

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

  • Recommend adaptive monitoring process adjustments based on feedback and data-driven trends in overall RBQM success measures

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

  • Act as a change agent, champion, subject matter expert and point of contact for adaptive monitoring concepts , leading study teams to understand and follow the best practices to achieve maximum benefit

  • Support and participate in internal and external audits and inspections as related to Takeda’s adoption of RBQM and Adaptive Monitoring

  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 , Risk-Based Monitoring, or Adaptive Monitoring roles

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

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

  Skills:

  • Experience in site monitoring and risk -based monitoring , including onsite and remote monitoring models

  • Experience in establishing risk-appropriate monitoring approaches, and assessing site monitoring compliance and quality/effectiveness

  • Knowledge of RBQM IT systems , targeted SDV/SDR tracking, and EDC systems

  • Demonstrated ability to effectively lead cross functional team meetings

  • Experience forming cross-functional collaborations ; strong interpersonal skills

  • Supports a culture of continual improvement and innovation; promotes knowledge sharing

  • Ability to influence without authorit y

  • Thinks creatively ; challenges the status quo

  Behavioral Competencies:

  • Pragmatic and willing to drive and support change

  • Comfortable with ambiguity

  • Excellent teamwork, organizational, interpersonal, and problem-solving skills

  • Assertive and collaborative communication sty le

  • C ritical think ing and growth mindset

  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

  • Demonstrated strong matrix leadership and communication skills

  TRAVEL REQUIREMENTS:

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

  Additional Information:

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

  • Base Salary Range: $130,000 to $186,000. 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.

  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

  Nevada - 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.

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