Job Description

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.

1. 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.
2. Drafts and oversee RBQM system set up specifications.
3. Perform the execution and review of the Study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks.
4. Raise signal and issues in RBQM systems and raise actions as appropriate in RBQM system.
5. Delivers timely high-quality analytics and supporting RBQM leads in communication to the cross-functional study team to identify resolution.
6. Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics in the RBQM system.
7. Perform QC study setup in RBQM system vs RBQM system specifications, if required.
8. Act as RBQM programmer on set up of KRIs, QTLs, data quality assessments as well as visualizations in the RBQM system, if required.
9. Perform the maintenance of the Risk-Based Quality Management (RBQM) system based on RBQM Plan requirements, data sources and structure.
10. Ensure appropriate status and process documentation are produced and maintained during the study.
11. Communicate and/or escalate serious risks and issues to the RBQM Lead, study team and/or management and Quality, as needed.
12. Ensure inspection readiness for clinical risk management and centralized monitoring activities.

Proven 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.