Centralized Monitoring Lead

Tech Observer; Ranchi; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Tech Observer seeks a Centralized Monitoring Lead to oversee RBQM and centralized monitoring for global medical device clinical investigations, ensuring data quality and subject safety. You will partner with Clinical Operations, Data Management, Biostatistics, and Regulatory Affairs to manage risk, compliance, and continuous quality improvement across study lifecycles.

You will drive the use of tools like Medidata Detect, Rave, Oracle Clinical One, and BI platforms to deliver actionable

Qualifications

• Experience leading RBQM for global medical device trials.
• Knowledge of ISO 14155, ICH-GCP, FDA, MDR compliance.
• Ability to drive data-driven risk mitigation and CAPA.

Responsibilities

• Lead RBQM strategy development and execution across global clinical investigations.
• Oversee centralized monitoring using clinical, safety, quality, and ops data.
• Review data trends, deviations, AEs/SAEs, and site performance; escalate risks.
• Collaborate with Clinical Ops, Data Management, Biostatistics, and Quality Assurance.

Skills

RBQM

Centralized monitoring

Data quality

Risk assessment

Stakeholder collaboration

Tools

Medidata Detect

Medidata Rave

Oracle Clinical One

Veeva Vault CDM

Power BI

Tableau

CTMS

Job description

Location: India/UK/Canada

Position Summary The Centralized Monitoring Lead is responsible for leading Risk-Based Quality Management (RBQM) and centralized monitoring activities across global medical device clinical investigations. This role partners closely with Clinical Operations, Data Management, Biostatistics, Medical Affairs, Quality Assurance, Regulatory Affairs, and Clinical Data Review teams to proactively identify risks, ensure data quality, protect subject safety, and maintain regulatory compliance throughout the study lifecycle The individual will lead centralized monitoring activities in accordance with ISO 14155, ICH-GCP, FDA, MDR, and applicable global regulatory requirements while driving data-driven decision-making and continuous quality improvement

Key Responsibilities (but not limited to)

• Risk-Based Quality Management (RBQM) - Lead the implementation and execution of Risk-Based Quality Management (RBQM) strategies for global medical device clinical investigations - Develop and maintain study-specific Risk Assessment and Categorization Tool (RACT), Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and centralized monitoring plans - Continuously evaluate study risks and recommend mitigation strategies - Lead periodic risk review meetings with cross-functional stakeholders
• Centralized Monitoring - Perform centralized monitoring activities using clinical, operational, safety, and quality data - Review data trends, protocol deviations, missing data, enrollment performance, adverse events, device deficiencies, monitoring findings, and site performance metrics - Identify data anomalies, outliers, fraud indicators, protocol non-compliance, and emerging risks - Escalate critical issues and recommend corrective and preventive actions (CAPA)
• Clinical Data Surveillance - Monitor - Enrollment and recruitment trends - Data entry timelines - Query aging - Protocol deviation - Missing data - Subject withdrawal - Device accountability - Adverse Events (AEs) - Serious Adverse Events (SAEs) - Device deficiencies - Endpoint data quality - Source Data Verification (SDV) strategy - Source Data Review (SDR
• Partner closely with - Clinical Operations-Clinical Monitoring - Data Management - Biostatistics - Medical Affairs - Clinical Safety - Regulatory Affairs - Quality Assurance - Clinical Data Review Team - Clinical Project Management
• Technology & Analytics Utilize RBQM and clinical systems including - Medidata Detect - Medidata Rave - Oracle Clinical One - Veeva Vault CDM - SSA - Power BI - Spotfire - Tableau - CTMS - RBQM dashboard Generate centralized monitoring reports and study dashboards
• Quality & Compliance - Ensure compliance with - ISO 14154 - ICH E6(R2)/(R3) - FDA regulations - EU MD - Company SOPs - Risk-Based Monitoring methodologies - Support sponsor audits and regulatory inspections - Participate in CAPA investigations and quality improvement initiatives