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 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 :
Responsible for all aspects of Takeda’s Risk Based Quality Management (RBQM) platforms including but not limited to technical configuration, conduct analyses using Central Statistical Monitoring (CSM), develop and maintain KRI & QTL library, maintain user access, troubleshooting, system integrations, and ongoing feature improvement to leverage a data-driven approach for managing risk across study teams and related functional areas.
+ Partake in development of advanced analytics for RBQM activities, including Quality Tolerance Limit (QTL) analysis and Key Risk Indicators (KRI) to support identification of important study issues which require monitoring, management, and adaptation of study plans
+ May map, manage, and design RBQM dataflows to integrate with other relevant clinical and operational databases at study, program, and enterprise level
+ Develop specifications and perform technical configuration of RBQM solution based on Study Risk Assessment (SRA)
+ Perform analyses in CSM Platform, interpret anomalies, and assist with explanation of complex findings
+ Summarize findings and communicate (written report or oral) results to stakeholders
+ Participate in developing and improving training materials for RBQM Enablement solutions
+ May provide internal and external training on RBQM solutions, as required
+ Develop and maintain library of QTLs and KRIs for studies across TAUs
+ Write signals based on critical data and critical processes as defined in the SRA
+ Assist RBQM Operations and study team with the investigation and explanation of complex CSM signals and outputs
+ Ensure that appropriate documentation is produced and maintained in the Trial Master File
+ May serve as technology Subject Matter Expert (SME) for RBQM platform and clinical data flow
+ Collaborate with Associate Director, Enablement to troubleshoottechnical issues related to RBQM solutions
+ Participate in the development, evaluation, and continuous improvement of RBQMand Adaptive Monitoring solutions
+ Assist RBQM Enablement leadership in responding to technology questions, requests, and audits
+ May perform line management of other (junior) staff within RBQM Enablement
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 5 years of experience in the pharmaceutical or CRO industry
+ Minimum of 3 years of experience in clinical data management and/or SAS programmingsupporting statistical analyses
+ Minimum of 1 years of managerial and supervisory experience
+ Advanced knowledge of broad drug development process and expertise in the cross-functional interfaces for the adoption of Risk Based Quality Management
+ Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICHE6 (GCP), CDISC standards, MedDRA, and WHODRUG
+ Solid understanding of the drug development process and clinical trial execution
+ Knowledge of RBQM IT systems
+ Experience with implementing RBQM Central Statistical Monitoring solutions
+ Strong technical understanding of statistical analyses, and the use of SAS programming language in the processing of clinical data, including data transformations, derivations, formatting, and reporting
+ Strong Technical understanding of how data flows across RBQM applications and the rest of Takeda’s R&D IT portfolio, including clinical and operational databases at study, program, and enterprise level
+ Demonstrated aptitude for data analytics and understanding of statistical concepts
+ Strong track record of building solid partnerships and cross-functional collaborations
+ Supports a culture of continual improvement and innovation; promotes knowledge sharing
+ Ability to influence without authority
+ Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo
+ Pragmatic and willing to drive and support change
+ Comfortable with ambiguity
+ Excellent teamwork, organizational, interpersonal, and problem-solving skills
+ Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
+ Demonstrated strong and collaborative matrix leadership and communication skills
+ Requires approximately 0-10% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel
Base Salary Range: $143,000.00 Range Min to $186,000.00 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.
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.
Massachusetts – Virtual