at Takeda Pharmaceuticals in Montpelier, Vermont, United States
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 Director 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.
+ As assigned to supportstudy execution teams, responsible for theimplementation of Adaptive Monitoringprocedures
+ Interpret critical data, critical processes, and key risks assigned for site monitoring mitigations to determine study specificsite monitoring requirements
+ Lead adaptive monitoring strategy meetings, engaging cross-functional study team members to identifystudy-level SDV and SDR strategies, aligned with Takeda’s adaptive monitoring schemas
+ Ensurerisk-basedmonitoring strategies are integrated in Takeda’sIQRMP and site monitoring functional plans,and ensures strategies are correctly configured in technology solutions (TSDV, Veeva CDMS, CTMS etc)
+ Partner with RBQM Operations team to ensure central monitoring findings and other signals identified for site monitoring mitigation are effectively communicated 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 coordinateMonitoring Oversight Visit activities 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 processadjustments 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 Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
+ Minimum of 6 years’ of experience in the pharmaceutical or CRO industry
+ Minimum of 2 years’ of experience in Risk Based Quality Management, Risk-Based Monitoring, or Adaptive Monitoring roles
+ Robust understanding of the drug development process and clinical trial execution
+ Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
+ Experience in site monitoring and risk-based monitoring, including onsite and remote monitoring models
+ Experience inestablishing 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 authority
+ Thinks creatively; challenges the status quo
+ Pragmatic and willing to drive and support change
+ Comfortable with ambiguity
+ Excellent teamwork, organizational, interpersonal, and problem-solving skills
+ Assertive and collaborative communication style
+ Critical thinking 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
+ Requires0- 10 % travel, potentially including overnight and international travel.
+ 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.
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.
Nevada – Virtual