Our values
- We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading-edge technology.
1.Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP.
2. Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards, conducting end of trial summarization of risk management activities for inclusion to Clinical study report.
3. Drafts and oversee RBQM system set up specifications.
4. Perform the execution and review of the Study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks.
5. Raise signal and issues in RBQM systems and raise actions as appropriate in RBQM system.
6. Delivers timely high-quality analytics and supporting RBQM leads in communication to the cross-functional study team to identify resolution.
7. Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics in the RBQM system.
8. Perform QC study setup in RBQM system vs RBQM system specifications, if required.
9. Act as RBQM programmer on set up of KRIs, QTLs, data quality assessments as well as visualizations in the RBQM system, if required.
10. Perform the maintenance of the Risk-Based Quality Management (RBQM) system based on RBQM Plan requirements, data sources and structure.
11. Ensure appropriate status and process documentation are produced and maintained during the study.
12. Communicate and/or escalate serious risks and issues to the RBQM Lead, study team and/or management and Quality, as needed.
13. Ensure inspection readiness for clinical risk management and centralized monitoring activities.
QualificationsProven experience in a clinical research environment, with experience in a pharmaceutical/biologics/biotechnology company.
Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program develop, and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry.
Experience and understanding of Risk Based Monitoring system preferred.
Experience with data analytics and data visualization technologies.
Strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts.
High degree of accuracy and attention to detail.
Experience and understanding of clinical trial data from various sources (e.g., Clinical devices, SDTM, RAVE, IRT, etc).
Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets.
Excellent English oral and written communication skills.
Skills Required
- Experience in a clinical research environment within a pharmaceutical, biologics, or biotechnology company
- Knowledge of clinical development processes, study design, conduct, closeout, and clinical program development
- Knowledge of clinical trial risk management concepts and principles in the pharmaceutical or CRO industry
- Experience with data analytics and data visualization technologies
- Strong critical thinking, analytical skills, and aptitude for mathematical and statistical concepts
- High degree of accuracy and attention to detail
- Experience understanding clinical trial data from sources such as clinical devices, SDTM, RAVE, and IRT
- Ability to collaborate in a team environment while managing changing priorities
- Excellent English oral and written communication skills
- Experience and understanding of a Risk-Based Monitoring system
Cytel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
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Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
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Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.
Cytel Insights
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
