Job DescriptionAccountabilities: - Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risks.
- Translate Study Risk Assessments into system specifications and configure RBQM technology accordingly.
- Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes.
- Acts 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.
- May perform line management of other staff within RBQM Data Enablement.
- Manage and optimize RBQM dataflows across study, program, and enterprise systems.
- Contributes to the creation of a lessons learned framework to ensure insights from RBQM activities are captured and applied to future studies with similar characteristics.
- Manage RBQM platform operations, including user access and system governance.
- Drive continuous enhancement of RBQM Data Enablement processes, tools, and capabilities.
- Develop training materials and deliver internal/external training on RBQM solutions as needed
- Partner with RBQM Operations, Business Systems, R&D IT, TIDE and vendors to support technology releases and data enablement.
- Assist RBQM Operations and study team with the investigation and explanation of complex Central Monitoring signals and outputs
- Serve as Subject Matter Expert for RBQM technology, data flows, documentation, inspections, audits, and complex signal interpretation as needed
- Identify novel ways to implement RBQM data enablement capabilities across the data continuum to drive operational efficiencies at the clinical trial level in partnership with RBQM Operations.
- Serve as primary point of contact for cross-functional escalation and issue management triage for Data Enablement.
- Oversee strategic vendor and partner ecosystem in partnership with GDO Business Operations, including FSPs, CROs, and technology providers, setting performance expectations, governing delivery, and ensuring alignment to RBQM operating principles and outcomes.
Education & Competencies (Technical and Behavioral): - Minimum of 8 years of experience in the pharmaceutical or CRO industry
- Minimum of 3 years of experience in Risk Based Quality Management
- Minimum of 2 years managerial and supervisory experience
- Robust understanding of the drug development process and clinical trial execution
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
- Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
- Knowledge of RBQM IT systems or other data analytic systems
- Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
- 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 and effectively communicate cross functionally with people of various levels
- Thinks creatively; challenges the status quo
- Thinks strategically, adopts breakthrough ideas
- Encourages open dialogue
- Takes decisive action and can prioritize
- Proactively takes steps to learn and grow
- Pragmatic and willing to drive and support change
- Comfortable with ambiguity
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Assertive and collaborative communication style
- Attention to detail and a critical thinker
- Embraces and demonstrates a diversity and inclusion mindset and sets an example for these behaviors for the organization
Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:Massachusetts - Virtual
U.S. Base Salary Range:$154,400.00 - $242,550.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
LocationsMassachusetts - Virtual
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes
