Job Title: Clinical Lead Analyst (CLA)
Location: India
Organization: Novotech (Global full-service CRO)
Employment Type: Full-time
1. Role Overview
The Clinical Lead Analyst (CLA) works closely with the Clinical Lead to manage the clinical delivery of projects. The role involves monitoring clinical deliverables, assessing project performance, ensuring compliance with regulatory requirements, identifying risks, and supporting overall project quality throughout the study lifecycle.
2. Minimum Qualifications & Experience
Total Experience: Minimum 3 years of work experience
Relevant Experience: At least 1.5 years in a Clinical Research Organization or equivalent role
Regulatory Knowledge:
Basic understanding of ICH-GCP, local regulatory guidelines, and research requirements
Technical Skills:
Proficiency in MS Excel, Word, and PowerPoint
Exposure to basic data analysis across study start-up, maintenance, and closeout
Additional Advantage:
Certification in Clinical Research
3. Key Responsibilities
A. Analytics & Reporting
Provide analytics, reports, status updates, and risk alerts to the Clinical Lead and clinical team.
Recommend risk mitigation strategies and support oversight of clinical deliverables.
B. Project Compliance & Oversight
Support Clinical Lead in ensuring adherence to:
Project scope (clinical)
Study protocol
SOPs
Regulatory guidelines
Study plans (e.g., CMAP, PD Management Plan, IQRMP, Recruitment Plan, IP Management)
Focus on applications, analytics, therapeutic requirements, blinding processes, project milestones, and quality metrics.
C. KPI Monitoring & Performance Management
Conduct periodic review of project-level KPIs.
Share status updates and analysis with stakeholders.
Follow up on open action items.
Monitor site performance indicators and suggest corrective actions.
D. Quality & Process Evaluation
Evaluate quality of clinical study processes.
Support Clinical Lead in monitoring protocol compliance and regulatory adherence.
E. Stakeholder Communication
Maintain effective communication with project/site-level stakeholders as delegated.
Ensure timely documentation and information flow.
F. System & Data Compliance
Ensure compliance across study systems such as:
CTMS (Clinical Trial Management System)
IWRS (Interactive Web Response System)
EDC (Electronic Data Capture)
G. Protocol Deviation & Administrative Support
Assist with protocol deviation management.
Perform administrative tasks to support Clinical Lead in project execution.
4. About Novotech
A leading global CRO headquartered in Sydney, Australia.
Presence across 34 offices in Asia-Pacific, North America, and Europe.
3000+ employees and 5000+ site partnerships.
Services across all clinical trial phases including regulatory submissions, medical monitoring, data management, and quality systems.
ISO 27001 and 9001 certified, ensuring highest standards of data security and quality.
5. Work Culture & Benefits
Novotech is committed to:
Gender equality and inclusive work culture
Equal opportunity for individuals from diverse backgrounds (LGBTIQ+, disability, caregivers, etc.)
Flexible work arrangements
Paid parental leave for both parents
Wellness and ongoing training programs
Responding to every application (Circle Back Initiative)
6. Team Culture
Strategic, collaborative, and insight-driven work environment
Empowered teams supported by senior leadership
Culture of partnership where every voice is valued
Opportunities to work on innovative, cutting-edge life sciences projects
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