Clinical Data Analyst- Remote
Posted 1 day ago by JS Consulting Solutions
Negotiable
Undetermined
Remote
Remote or District of Columbia
Summary: Candidates must have a minimum of 2 years of central monitoring experience in a clinical environment. The role involves supporting risk-based quality management (RBQM) and centralized monitoring activities across clinical trials, focusing on developing Key Risk Indicators (KRIs) and analyzing data dashboards. Ideal candidates should have a strong background in clinical research, preferably as a CRA, along with experience in centralized monitoring and data review. This position is contract-hire and fully remote for candidates residing in MD, DC, and VA.
Key Responsibilities:
- Lead the development and implementation of centralized monitoring plans, including defining study-specific risk indicators (KRIs, QTLs) aligned with protocol requirements.
- Design, develop, and maintain central monitoring dashboards and visualizations to support ongoing risk assessment.
- Contribute to and standardize RBQM frameworks, templates, tools, and processes across studies.
- Analyze study data outputs and dashboards to identify trends, risks, and signals related to site performance, data quality, and protocol compliance.
- Perform proactive signal detection and evaluation, recommending targeted site-level actions and escalations to CRAs and study teams.
- Maintain and manage clinical risk logs, ensuring proper documentation and follow-through on mitigation strategies.
- Partner with Clinical Operations, Data Management, and Analytics teams to ensure proper setup and functionality of central monitoring platforms.
- Support protocol review to ensure feasibility of KRI/QTL data collection, reporting, and monitoring.
- Serve as a subject matter expert (SME) for centralized monitoring across project teams.
- Provide training and guidance to study teams on interpreting central monitoring outputs and making data-driven decisions.
- Mentor junior team members and support the development of best practices in centralized monitoring.
- Drive continuous improvement initiatives, including SOP development, process optimization, and adoption of new tools or technologies.
- Contribute to proposal development, bid defenses, and budget planning as needed.
- Ensure adherence to ICH-Google Cloud Platform, FDA regulations, and RBQM guidelines.
- Support inspection readiness, audits, and post-inspection activities.
- Maintain high-quality documentation and ensure timelines and deliverables are met.
Key Skills:
- Minimum 3+ years of centralized monitoring experience within a CRO or clinical research environment.
- Demonstrated experience in developing and managing KRIs/QTLs, contributing to central monitoring plans, and evaluating data dashboards for signal detection and risk identification.
- Prior experience as a Clinical Research Associate (CRA) or equivalent monitoring role.
- Experience with central monitoring platforms, clinical data systems, and dashboards.
- Strong analytical skills with the ability to interpret complex datasets and identify trends.
- Exposure to programming or data tools (e.g., SAS, R, Python, SQL, or visualization tools like Power BI/Tableau) is highly preferred.
- Deep understanding of ICH-Google Cloud Platform, FDA regulations, and RBQM methodologies.
- Strong communication and stakeholder management skills in cross-functional and client-facing environments.
- Proven ability to solve problems, prioritize, and manage multiple studies in a fast-paced setting.
- High attention to detail with strong quality control and documentation skills.
- Experience in Infectious Disease, Oncology, or Government-sponsored trials is preferred.
- Experience mentoring teams and developing central monitoring processes or SOPs is preferred.
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: Clinical Data Analyst
Location: Remote
Duration: 6-12+ months Contract to Hire
Summary:
Candidates must have a minimum of 2 years of central monitoring experience in a clinical environment.
We are seeking an experienced Central Monitoring Specialist to support risk-based quality management (RBQM) and centralized monitoring activities across clinical trials. This role is ideal for candidates who bring hands-on experience developing Key Risk Indicators (KRIs), contributing to central monitoring strategies, and analyzing data dashboards to identify actionable signals. The ideal candidate will have a strong background in clinical research (preferably as a CRA), combined with experience in centralized monitoring, data review, and a working knowledge of analytical or programming tools. This position is contract-hire and fully remote for candidates that live in MD, DC, and VA.
Key Responsibilities
Central Monitoring Strategy & Execution
- Lead the development and implementation of centralized monitoring plans, including defining study-specific risk indicators (KRIs, QTLs) aligned with protocol requirements.
- Design, develop, and maintain central monitoring dashboards and visualizations to support ongoing risk assessment.
- Contribute to and standardize RBQM frameworks, templates, tools, and processes across studies.
Data Review, Signal Detection & Risk Management
- Analyze study data outputs and dashboards to identify trends, risks, and signals related to site performance, data quality, and protocol compliance.
- Perform proactive signal detection and evaluation, recommending targeted site-level actions and escalations to CRAs and study teams.
- Maintain and manage clinical risk logs, ensuring proper documentation and follow-through on mitigation strategies.
Study Support & Cross-Functional Collaboration
- Partner with Clinical Operations, Data Management, and Analytics teams to ensure proper setup and functionality of central monitoring platforms.
- Support protocol review to ensure feasibility of KRI/QTL data collection, reporting, and monitoring.
- Serve as a subject matter expert (SME) for centralized monitoring across project teams.
- Provide training and guidance to study teams on interpreting central monitoring outputs and making data-driven decisions.
Process Improvement & Leadership
- Mentor junior team members and support the development of best practices in centralized monitoring.
- Drive continuous improvement initiatives, including SOP development, process optimization, and adoption of new tools or technologies.
- Contribute to proposal development, bid defenses, and budget planning as needed.
Compliance & Quality
- Ensure adherence to ICH-Google Cloud Platform, FDA regulations, and RBQM guidelines.
- Support inspection readiness, audits, and post-inspection activities.
- Maintain high-quality documentation and ensure timelines and deliverables are met.
Qualifications
Required Experience
- Minimum 3+ years of centralized monitoring experience within a CRO or clinical research environment.
- Demonstrated experience in:
- Developing and managing KRIs/QTLs
- Contributing to central monitoring plans
- Evaluating data dashboards for signal detection and risk identification
- Prior experience as a Clinical Research Associate (CRA) or equivalent monitoring role.
Technical & Analytical Skills
- Experience with central monitoring platforms, clinical data systems, and dashboards.
- Strong analytical skills with the ability to interpret complex datasets and identify trends.
- Exposure to programming or data tools (e.g., SAS, R, Python, SQL, or visualization tools like Power BI/Tableau) is highly preferred.
Core Competencies
- Deep understanding of ICH-Google Cloud Platform, FDA regulations, and RBQM methodologies.
- Strong communication and stakeholder management skills in cross-functional and client-facing environments.
- Proven ability to solve problems, prioritize, and manage multiple studies in a fast-paced setting.
- High attention to detail with strong quality control and documentation skills.
Preferred Qualifications
- Experience in Infectious Disease, Oncology, or Government-sponsored trials.
- Experience mentoring teams and developing central monitoring processes or SOPs.