Clinical Lead Analyst

Job Summary

The Clinical Lead Analyst (CLA) works collaboratively with Clinical Lead in managing clinical delivery of the project, by closely monitoring the clinical deliverables, project performance schedule, compliance, risks, quality of the project.

Minimum Qualifications Experience

• Requires minimum of 3 years of work experience, with minimum 1.5 years of relevant experience in a clinical research organization or equivalent role.
• Basic knowledge of applicable research and regulatory requirements, i.e. International Conference on Harmonization - Good Clinical Practice and relevant local laws, regulations, and guidelines.
• Knowledge of Microsoft Applications including but not limited to Microsoft Excel, Word and PowerPoint.
• Exposure to basic data analysis required for projects during start-up, maintenance and close outs.
• Certification course in Clinical Research will be an added advantage.

Responsibilities

• CLA provides analytics, reports, status update, risk alerts and required mitigation recommendations to the Clinical Lead and rest of the clinical team throughout the lifecycle of the project.
• CLA supports the Clinical Lead with tools to ensure efficient oversight of clinical deliverables of a project and to ensure adherence to project scope (clinical), protocol, SOPs, applicable regulations, and study plans (CMAP, PD management plan, recruitment plan, IQRMP, IP management, etc.) focusing on applications, analytics, therapeutics, regional requirements, blinding processes, project milestones, and quality perspectives.
• Conducts periodic review of project KPIs, shares status/analysis, follows up for open action items in accordance to clinical lead s directions.
• Monitors site-performance parameters at study level and makes recommendations for timely corrective actions under the guidance of Clinical Lead.
• Evaluates the quality of study processes (clinical) and supports the Clinical in monitoring quality of conduct of the protocol and adherence to applicable regulations.
• Establishes and maintains effective project/site-level communications with relevant stakeholders (for clinical) as delegated by Clinical Lead.
• Ensures compliance on study databases (Clinical Trial Management System (CTMS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC) etc.)
• Supports Clinical Lead in protocol deviation management.
• Performs assigned administrative tasks to support Clinical Lead with project execution.

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