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