ICON plc Hiring for RBQM Lead Job in Bangalore and Chennai with clinical risk management and ICH expertise. Apply online now.
Clinical research professionals with strong experience in Risk-Based Quality Management (RBQM) now have an excellent leadership opportunity with a globally reputed CRO. ICON plc is inviting applications for the position of RBQM Lead in India. This role is designed for experienced professionals who can drive proactive, risk-focused quality oversight across global clinical trials and strengthen inspection readiness standards.
If you have expertise in RBQM frameworks, cross-functional collaboration, and regulatory compliance, this could be a major career advancement opportunity in clinical operations and quality governance. ICON plc Hiring for RBQM Lead Job
Company Overview
ICON plc is a leading global Contract Research Organization (CRO) delivering healthcare intelligence and end-to-end clinical development services to pharmaceutical, biotechnology, and medical device companies. With a strong international presence, ICON supports innovative therapies through advanced research solutions, operational excellence, and regulatory expertise. The organization promotes a performance-driven and inclusive work culture, encouraging continuous learning and leadership development. ICON plc Hiring for RBQM Lead Job
Job Location & Employment Type
- Locations (India): Bangalore, Chennai
- Other Global Locations: Lisbon (Portugal), Sofia (Bulgaria)
- Work Model: Office-Based or Work from Home (as per business requirements)
- Employment Type: Full-Time
- Job Requisition ID: JR140696
This is a global-facing role offering flexibility in work arrangements while collaborating with international clinical research teams.
Department & Position Details
- Department: Clinical Quality & Risk Management
- Position Title: RBQM Lead
- Internal Role Title: Lead Business Operations Specialist
- Level: Senior / Leadership Role
The selected candidate will function as a subject matter expert (SME) in Risk-Based Quality Management, supporting study-level and program-level risk oversight initiatives across the clinical trial lifecycle.
Key Roles & Responsibilities
1. RBQM Planning & Risk Assessment
- Lead the development and execution of study-level Quality and Risk Management Plans aligned with protocol objectives.
- Facilitate cross-functional workshops to identify Critical-to-Quality (CtQ) factors, essential data points, and key clinical processes.
- Oversee initial and ongoing risk assessments throughout the trial lifecycle.
- Ensure risk mitigation strategies are properly documented, actionable, and compliant with global regulatory standards.
- Confirm that risk controls are aligned with study design, timelines, and operational objectives.
ICON plc Hiring for RBQM Lead Job
2. Cross-Functional Collaboration
- Partner with Clinical Operations, Data Management, Biostatistics, and other core functions to assess data flows and critical data pathways.
- Provide expert input into Risk-Based Monitoring (RBM) strategies, including targeted Source Data Verification (SDV) and Source Data Review (SDR) approaches.
- Conduct quality gate reviews to verify integration of risk mitigation strategies into functional plans.
- Drive alignment across global stakeholders in a matrixed organizational environment.
3. Ongoing Risk Oversight & Surveillance
- Lead and facilitate Risk Review Meetings (RRMs) to assess emerging risks and document mitigation actions.
- Monitor study-level risk indicators to ensure ongoing oversight remains effective and proportionate.
- Provide trend analysis, actionable insights, and meaningful reporting to leadership.
- Update risk documentation in response to protocol amendments or new risk signals.
4. Governance & Continuous Improvement
- Support RBQM governance frameworks at program and organizational levels.
- Contribute to continuous improvement initiatives aimed at strengthening RBQM maturity.
- Promote a culture of proactive quality management and inspection readiness.
- Mentor team members to enhance RBQM understanding and implementation across studies.
ICON plc Hiring for RBQM Lead Job
Eligibility Criteria
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related scientific discipline.
- Advanced degree (M.Pharm, MSc, MPH, or equivalent) preferred but not mandatory.
Experience Requirements
- Extensive experience in clinical research within global or matrixed environments.
- Significant hands-on experience in one or more of the following areas:
- Risk-Based Quality Management (RBQM)
- Clinical Operations
- Centralized Monitoring
- Clinical Risk Management
- Clinical Data Science
- Demonstrated experience implementing RBQM methodologies across multiple clinical programs.
- Proven leadership in cross-functional project execution.
Technical Skills & Expertise
- Strong knowledge of ICH E6 (R2/R3), ICH E8, and their practical application within RBQM frameworks.
- Deep understanding of clinical trial workflows, monitoring strategies, and regulatory compliance.
- Experience designing and reviewing Risk-Based Monitoring (RBM) strategies.
- Ability to translate regulatory expectations into operational processes.
- Strong analytical thinking and risk anticipation capabilities.
Behavioral Competencies
- Strategic thinker with problem-solving orientation.
- Excellent stakeholder engagement and communication skills.
- Ability to work effectively in global, complex environments.
- Passion for mentoring and driving organizational quality improvements.
- Commitment to collaboration and inclusive work culture.
Salary & Benefits
Compensation for the RBQM Lead position will be offered as per company norms, based on experience and qualifications.
Employees may receive additional benefits such as:
- Paid annual leave entitlements
- Comprehensive health insurance coverage
- Retirement and long-term financial planning options
- Employee Assistance Programme (EAP) support
- Life insurance coverage
- Flexible, country-specific optional benefits
Benefits are structured to promote work-life balance and long-term professional stability. ICON plc Hiring for RBQM Lead Job
Selection Process
The recruitment process typically includes:
- Application review and shortlisting
- Technical interview(s) with clinical and quality leadership teams
- Behavioral and leadership assessment
- HR discussion and final offer
Shortlisted candidates will be contacted directly for further evaluation. ICON plc Hiring for RBQM Lead Job
How to Apply
Interested candidates should apply online through the official ICON careers portal using Job Requisition ID JR140696. Applicants are advised to highlight their RBQM experience, risk assessment expertise, and global collaboration exposure in their CV.
Early application is encouraged, as the position may close once suitable candidates are selected. ICON plc Hiring for RBQM Lead Job
Important Dates
- Application Deadline: Not specified (Apply as early as possible)
Why Apply for This Pharma Job?
- Opportunity to lead RBQM strategy at a global CRO.
- Exposure to international regulatory frameworks and inspection readiness initiatives.
- Leadership-level role with strategic impact across multiple studies.
- Flexible office or remote work model.
- Career growth in clinical quality governance and risk management.
This role is ideal for experienced clinical research professionals seeking to transition into high-impact leadership positions within global quality and risk management functions. ICON plc Hiring for RBQM Lead Job
Important Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not associated with ICON plc or any other organization mentioned above. We provide job-related information for awareness purposes only. Candidates are advised to verify complete details through the official company website before applying. ICON plc Hiring for RBQM Lead Job
If you have strong RBQM expertise and aspire to lead risk-based clinical quality initiatives, this is your opportunity to advance your career. Submit your application today and take the next step toward a global leadership role in clinical research. ICON plc Hiring for RBQM Lead Job
