Analysis Skills, Best Practices, Biology, Biostatistics, Biotech and Pharmaceutical, Clinical Monitoring, Clinical Support, Clinical Trial, Communication Skills, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Data Management, Detail Oriented, Documentation, ICH Regulations, Leadership, Nursing, Operations Processes, Pharmacy, Presentation/Verbal Skills, Process Improvement, Quality Management, Quality Monitoring, RMON, Reporting Dashboards, Risk, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Statistics, Strategic Planning, Writing Skills
Employment as a Contingent Worker aligns well with individuals seeking career flexibility and non-traditional work arrangements, while also being motivated to produce exceptional results in prominent roles. Magnit Direct Source is a service provided by Magnit Global that connects top-tier talent directly to an industry-leading company. Daiichi Sankyo, Inc. and Magnit Global, in collaboration, offer flexible contingent assignments across diverse projects creating opportunities for engaging work. As a Contingent Worker, you will not be employed Daiichi Sankyo, Inc. You will be employed by our Managed Service Provider, Magnit Global, which oversees the majority of our temporary contract recruitment.
Location: Remote in United States but must reside in EST time zone
Responsibilities
RBQM & Quality Risk Management
- Support implementation and execution of Daiichi Sankyo’s RBQM framework in alignment with ICH E6(R3), ICH E8(R1), and ICH Q9 principles
- Contribute to CTQ (Critical-to-Quality) identification, risk assessments, and ongoing risk review activities at study and program level.
- Support development, review, and maintenance of RBQM deliverables (e.g., risk assessments, monitoring strategies, RBQM plans, issue escalation documentation)
- Assist with interpretation and application of RBQM governance expectations, including differentiation between risks, issues, deviations, and quality events.
- Support CRO oversight activities related to RBQM, including review of CRO‑delivered monitoring outputs, risk assessments, and mitigation actions to ensure alignment with Daiichi Sankyo RBQM expectations.
Central & Clinical Monitoring Support
- Support centralized/statistical monitoring (CSM) activities, including review and interpretation of KRIs, QTLs, and other risk indicators.
- Collaborate with internal teams and CROs to ensure monitoring outputs are reviewed, understood, and translated into actions
- Support cross-functional discussions around emerging risks, signals, and mitigation strategies
- Assist in ensuring alignment between centralized monitoring outputs and on-site/remote monitoring activities.
Cross-Functional & Vendor Collaboration
Partner closely with Clinical Operations, Biostatistics, Data Management, and Quality to support integrated oversight.
- Participate in and/or prepare content for RBQM-related governance forums, workshops, and working sessions
- Support interaction with CROs and external vendors to ensure RBQM expectations are understood and executed consistently
- Contribute to inspection readiness activities related to RBQM and quality oversight.
Process Improvement & Documentation
- Support continuous improvement of RBQM processes, tools, templates, and guidance based on internal experience, inspection learnings, and external best practices.
- Assist with drafting and reviewing SOPs, guidance documents, training materials, and presentations related to RBQMHelp standardize RBQM practices across studies while allowing for protocol- and risk-specific tailoring.
Required Qualifications
- Strong background in one or more of the following:
- Risk-Based Quality Management (RBQM)
- Quality Risk Management (QRM)
- Clinical Trial Operations (Global or Regional)
- Solid understanding of clinical trial conduct, lifecycle, and inspection expectations.
- Familiarity with ICH guidelines relevant to RBQM (E6, E8, Q9)
- Experience working with KRIs, QTLs, CTQs, and risk assessments in a clinical trial setting
- Ability to work effectively in a matrixed, cross-functional, and global environment
- Strong written and verbal communication skills; ability to clearly articulate risks, issues, and recommendations
- Comfortable working with data outputs, dashboards, and monitoring summaries (hands‑on analysis not required, but interpretation is)
Skills
Preferred Experience
- Prior experience supporting RBQM within a pharmaceutical company, biotech or CRO.
- Exposure to centralized/statistical monitoring platforms (e.g., Fortrea Xcellerate, CluePoints, Medidata, IQVIA tools).
- Experience supporting vendor oversight or CRO-delivered monitoring models
- Inspection preparation or inspection support experience related to quality oversight or monitoring
- Advanced degree in life sciences, statistics, pharmacy, nursing, or related field (or equivalent experience)
Factors for Success at Daiichi Sankyo
- Pragmatic and solution-oriented; able to balance rigor with operational reality
- Comfortable operating with evolving processes and helping shape “what good looks like.”
- Detail-oriented, with strong judgment around what is truly critical to quality
- Able to work independently while staying aligned with RBQM leadership and governance expectations
Hourly Pay Rate Range (dependent on location, experience, expectation)
The pay range that Magnit reasonably expects to pay for this position is: $ 52-$67/hr
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
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