Description:
Responsibilities:
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Lead operational execution of assigned clinical trials under both:
- In-house managed models (direct CRA/site oversight), and
- Outsourced models (full-service or functional CRO partnerships)
- Ensure consistent application of sponsor SOPs regardless of delivery model
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Drive study start-up, enrollment, and close-out milestones across all regions
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Directly manage CRAs and/or Lead CRAs assigned to in-house managed studies
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Provide functional oversight of IHCRAs - Assign, prioritize, and track IHCRA work activities, including:
o Site document review and tracking
o Remote monitoring support and follow-up
o Query and action item tracking
o TMF/eTMF filing support and completeness checks
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Review IHCRA outputs for quality, timeliness, and compliance
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Provide feedback, coaching, and training input to IHCRAs in collaboration with line managers
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Assign sites, review monitoring plans, and ensure adequate site coverage
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Review monitoring visit reports, follow-up letters, and issue resolution
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Coach and mentor CRAs to ensure monitoring quality and compliance
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Provide sponsor oversight of CROs, vendors, and functional service providers
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Review and approve CRO deliverables (monitoring plans, reports, metrics, TMF status)
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Ensure CRO performance aligns with contracted scope, KPIs, timelines, and quality standards
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Lead governance meetings, performance reviews, and escalation management
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Ensure clear documentation of sponsor oversight activities per ICH E6(R2/R3)
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Experience supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional 100% SDV monitoring models, as appropriate to study design, risk profile, and regulatory expectations
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Ability to transition studies between RBM and 100% SDV approaches based on protocol requirements, inspection feedback, or sponsor risk assessments
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Oversight of monitoring plans to ensure:
o Appropriate SDV/SDR levels
o Centralized monitoring outputs are reviewed and actioned
o On-site, remote, and hybrid monitoring approaches are appropriately applied
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Oversee protocol deviations, CAPAs, and quality issues
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Identify operational risks early and implement mitigation strategies
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Act as escalation point for complex site, CRA, or CRO issues
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Partner with sites to support enrollment, retention, and protocol adherence
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Ensure studies are inspection-ready at all times
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Support and participate in regulatory inspections and audits (FDA, EMA, Health Authorities)
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Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs)
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Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, and Supply Chain
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Provide operational input into protocols, ICFs, feasibility, and country/site strategy
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Support investigator meetings, site trainings, and study communications
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Provide regular study status updates to senior management
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Maintain oversight trackers, risk logs, issue logs, and KPI dashboards
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Ensure accurate documentation of decisions, deviations, and actions
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Any other duties as assigned by Supervisor.
Requirements:
Qualifications
Education
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Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (required)
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Advanced degree preferred
Experience
- 8+ years of clinical research experience, including management of both in-house and outsourced trials, with 6+ years of onsite monitoring CRA experience, including people management and CRO oversight exposure
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Experience managing global or multi-regional Phase I–III trials preferred
Core Competencies & Skills
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Strong understanding of sponsor oversight responsibilities under ICH-GCP
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Hands-on experience with both direct CRA management and CRO governance
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Expertise in RBM, centralized monitoring, and quality risk management
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Strong leadership, communication, and stakeholder management skills
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Ability to manage multiple studies and vendors simultaneously
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Proficiency with CTMS, eTMF, and clinical systems
Preferred Experience
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Sponsor-side experience in biotech or pharmaceutical companies
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Experience transitioning studies between in-house and outsourced models
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Experience in complex or rare disease trials
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Prior inspection support experience
Travel
Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections
