Associate Director, RBQM Enablement - REMOTE
- Connecticut - Virtual, Connecticut
- Start date
- Mar 3, 2023
- Clinical, Clinical Project Management, Clinical Trials, Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
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.
As the Associate Director, RBQM Enablement, you will be 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.
- Support 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
- 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
- Accountable for RBQM platform administration and user access management
- Support and participate in developing and improving training materials for RBQM solutions
- 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
- Identify, assess, and roll-out vendor technology enablement for CSM in collaboration with the RBQM Strategy & Insights
- Ensure that appropriate documentation is produced and maintained in the Trial Master File
- Serve as technology Subject Matter Expert (SME) for RBQM platform and clinical data flow
- Collaborate with R&D IT to troubleshoot technical issues related to RBQM solutions
- Participate in the development, evaluation, and continuous improvement of RBQM and Adaptive Monitoring solutions
- Assist CQM leadership in responding to technology questions, requests, and audits
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 8 years of experience in the pharmaceutical or CRO industry
- Minimum of 5 years of experience in clinical data management and/or SAS programming supporting statistical analyses
- Minimum of 3 years of managerial and supervisory experience
- Experience with all phases of development in one or more therapeutic areas preferred
- 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, ICH E6 (GCP), CDISC standards, MedDRA, and WHODRUG
- Robust 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
Base Salary Range: $143,500-205K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.
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.LocationsConnecticut - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
Stock Symbol: TAK
650 East Kendall Street
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