Clinical Insights Analyst I

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Assists the cross-functional study team and RBQM Leads in Protocol Risk Assessment, including risk identification and evaluation within the Risk MAP.

• Aids RBQM Leads in the selection and implementation of Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs), as well as other relevant assessments and dashboards, conducting end-of-trial summarization of risk management activities for incorporation into the Clinical study report.

• Prepares and oversees the specifications for RBQM system setup.

• Executes and reviews the Study’s assessments and analyses, diagnosing and elucidating anomalies found in data and associated risks.

• Signals and addresses issues within the RBQM systems, taking appropriate actions in the RBQM system as necessary.

• Provides timely, high-quality analytics and supports RBQM leads in communicating with the cross-functional study team to identify resolutions.

• Collaborates with the designated programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics within the RBQM system.

• Conducts quality control of study setup in the RBQM system against RBQM system specifications when required.

• Acts as the RBQM programmer for the establishment of KRIs, QTLs, data quality assessments, and visualizations in the RBQM system as needed.

• Maintains the Risk-Based Quality Management (RBQM) system in accordance with RBQM Plan requirements, data sources, and structure.

• Ensures that appropriate status and process documentation are created and maintained throughout the study.

• Communicates and/or escalates significant risks and issues to the RBQM Lead, study team, and/or management and Quality as necessary.

• Guarantees inspection readiness for clinical risk management and centralized monitoring activities.

⛳️ Requirements

• Demonstrated experience in a clinical research setting, particularly within a pharmaceutical, biologics, or biotechnology company.

• Solid understanding of clinical development processes, including the concepts and principles of study design, execution, and closure, along with knowledge of clinical program development and clinical trials risk management principles within the Pharma or CRO industry.

• Familiarity with Risk Based Monitoring systems is preferred.

• Experience with data analytics and data visualization tools.

• Strong analytical skills, critical thinking abilities, and a solid grasp of mathematical and statistical concepts.

• High level of accuracy and meticulous attention to detail.

• Familiarity with clinical trial data from various sources (e.g., Clinical devices, SDTM, RAVE, IRT, etc.).

• Ability to collaborate effectively within a team environment while managing shifting priorities to meet goals and targets.

• Exceptional English verbal and written communication skills.

🏝️ Benefits

• We believe in applying scientific rigor to uncover the full potential inherent in data.

• We foster intellectual curiosity and encourage everyone to tackle new challenges with enthusiasm and a passion for discovery.

• We value collaboration and invite diverse perspectives, leveraging a variety of talents to create a multitude of possibilities.

• We cherish innovation and seek intelligent solutions through cutting-edge technology.