Site and Monitoring Health Lead – Clinical Trial Oversight (Remote, India)
Job ID: R0000038570
Location: India (Remote)
Category: Clinical Trials
Employment Type: Full Time
Company: Parexel
Job Overview
ThePharmaDaily.com is featuring an advanced career opportunity for a Site and Monitoring Health Lead (SMH Lead) with Parexel. This remote, site-facing role plays a strategic part in safeguarding clinical trial quality, ensuring effective monitoring oversight, and strengthening sponsor-level quality control across investigator sites.
The SMH Lead applies deep knowledge of ICH-GCP, global regulatory standards, and clinical monitoring expertise to evaluate CRO monitoring effectiveness and enhance risk-based oversight. This role reports to the FSP Manager, with functional direction from the client’s Associate Director (or above) within the Site and Monitoring Health Team.
Experience Level
Senior / Lead Level
Experience Required:
Significant direct clinical monitoring experience within a CRO or pharmaceutical company.
Prior Lead CRA or monitoring management experience preferred.
Experience across Phase I–III clinical trials; exposure to rare and prevalent disease studies preferred.
Previous audit and regulatory inspection experience strongly preferred.
Key Responsibilities
Monitoring Oversight & Risk-Based Quality Management
Implement oversight encounters including site risk analysis, data reviews, monitoring visit report assessments, Sponsor Oversight Visits, and system/data spot checks.
Prepare high-quality Sponsor Oversight Visit reports within defined timelines.
Apply a risk-based approach to review critical-to-quality data at site and study levels.
Develop and implement Study Specific Oversight Plans (SSOPs) aligned with the Risk Management Plan (Risk MAP).
Conduct root cause analysis and recommend mitigation strategies to study management and CRO partners.
Support inspection readiness and regulatory audit preparation.
Clinical Site Engagement & Relationship Management
Build and maintain strong relationships with investigators and site staff.
Identify potential sites for new studies and support less experienced research sites.
Ensure sites are engaged, supported, and operationally ready for recruitment and trial execution.
Collaborate closely with Clinical Risk and Analytics teams to identify site outliers and trends.
Operational Leadership
Lead oversight and trend meetings with study teams and CROs to address risks, compliance issues, and performance trends.
Ensure alignment with International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines and global regulatory standards.
Stay updated with evolving regional and international regulatory requirements.
Compliance & Process Adherence
Maintain compliance with Parexel processes, SOPs, and training requirements.
Ensure timely submission of documentation, timesheets, and expense reports.
Maintain up-to-date CV and regulatory documentation.
Educational Qualifications
Bachelor’s Degree required (Life Sciences or related discipline preferred).
Advanced clinical or healthcare degree preferred, including:
Registered Nurse (RN)
Master of Public Health (MPH)
Master of Science (MS)
Master of Arts (MA)
MBA
Doctor of Pharmacy (PharmD)
Required Skills and Competencies
Strong knowledge of ICH-GCP, global regulatory frameworks, and sponsor oversight practices.
Demonstrated expertise in Risk-Based Monitoring (RBM) and centralized risk management strategies.
Excellent analytical and critical thinking skills.
Proven ability to conduct root cause analysis and recommend corrective actions.
Strong stakeholder management and communication skills (written and verbal).
Proficiency in Microsoft Office (Excel, Word, PowerPoint) and ability to adapt to internal systems.
Ability to travel approximately 50%, including domestic and international travel.
High adaptability and ability to manage competing priorities in dynamic clinical environments.
Work Environment
Fully remote role based in India.
Requires flexibility in schedule and frequent travel within assigned region.
Involves collaboration across global cross-functional clinical teams.
Why Consider This Role
Strategic sponsor-facing oversight position within a leading global CRO.
Opportunity to influence site performance, risk mitigation, and clinical quality standards.
Engagement in multinational clinical trials across therapeutic areas.
Career progression into senior clinical oversight and quality leadership roles.
About Parexel
Parexel is a global clinical research organization (CRO) providing clinical development services, regulatory consulting, and market access solutions to pharmaceutical and biotechnology companies worldwide. The organization is committed to delivering high-quality clinical trial execution and regulatory excellence.
SEO Keywords
Site Monitoring Health Lead India, Sponsor Oversight Jobs, Clinical Trial Oversight Remote India, Lead CRA Jobs India, Risk Based Monitoring Careers, CRO Clinical Oversight Roles, ICH GCP Monitoring Jobs, Clinical Quality Lead 2026.
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