Senior Central Monitor – India
Location: India (Remote/Onsite)
Employment Type: Permanent, Full-Time
Professional Level: Senior
About the Role
Indero, a leading Contract Research Organization (CRO) specializing in dermatology, is seeking a Senior Central Monitor to support our risk-based monitoring strategy for clinical trials. Centralized monitoring is a critical component of Risk-Based Quality Management (RBQM), enabling proactive review of accumulating study data to identify trends, outliers, and potential risks across study sites and countries.
The Senior Central Monitor will lead study-specific analytics setup, conduct centralized statistical data reviews, and facilitate risk identification and mitigation, ensuring high-quality, compliant clinical trial conduct. This role requires strong collaboration with cross-functional teams including Clinical Operations, Data Management, Biostatistics, and Project Management.
Key Responsibilities
Centralized Monitoring and Data Review
Lead setup of study-specific tools, analytics, and centralized monitoring plans for data review, ensuring alignment with study protocols and RBQM principles.
Conduct centralized statistical reviews of study data from study initiation to database lock, identifying emerging or existing risks to study data integrity and operational processes.
Generate centralized monitoring reports and lead review meetings with study teams to communicate findings and risks.
Participate in study-specific risk assessment meetings and contribute to proactive risk management strategies.
Team Leadership and Mentorship
Provide training and guidance to junior or new team members on centralized monitoring processes and data analysis techniques.
Organize and delegate tasks within the team to ensure timely, high-quality completion of data reviews.
Support process improvements to enhance efficiency, quality, and compliance of centralized monitoring activities.
Cross-Functional Collaboration
Work closely with Clinical Operations, Data Management, Biostatistics, and Project Management teams to ensure accurate, timely, and actionable data insights.
Contribute to the identification of trends, anomalies, and data quality issues, escalating risks appropriately to management.
Support department initiatives, database updates, and other tasks as assigned.
Required Qualifications
Education
Bachelor’s degree in a field relevant to clinical research.
Experience
Minimum 3 years of centralized statistical monitoring experience with a total of 8+ years in clinical research across operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
Strong understanding of Risk-Based Quality Management (RBQM), clinical trial processes, and data integrity principles.
Experience with clinical trial systems including EDC, IRT, CTMS, and other electronic data management tools.
Hands-on experience in reviewing and analyzing clinical trial data, identifying trends, and assessing data quality.
Knowledge of descriptive statistics (means, medians, significance, confidence intervals) and ability to interpret analytical outputs.
Skills & Attributes
Excellent oral and written English communication skills.
Ability to prioritize, plan, and manage workload across multiple projects in a fast-paced environment.
Strong organizational, analytical, and problem-solving skills.
Knowledge of Good Clinical Practices (GCP) and regulatory guidelines including FDA and Health Canada.
Proficient in MS Office (Word, Excel, PowerPoint) and capable of quickly learning new analytics tools and systems.
Comfortable working in non-traditional work environments and flexible schedules.
Work Environment & Benefits
Permanent full-time position based in India.
Flexible work schedule to support a healthy work-life balance.
Continuous learning and professional development opportunities.
Collaborative, innovation-driven work culture emphasizing reliability and responsiveness.
About Indero
Indero is a global CRO specializing in dermatology, delivering high-quality clinical research services since 2000. With operations spanning North America, Europe, and India, Indero provides biotech and pharmaceutical clients with end-to-end clinical trial solutions, including centralized monitoring, risk-based quality management, and clinical operations support.
Indero is committed to equity, diversity, and inclusion, providing accommodations for applicants with disabilities throughout the recruitment process. Only candidates legally authorized to work in India will be considered.
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