Clinical Operations Manager

Description:

Responsibilities:

• 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
• 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, 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 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 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 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 deviations, CAPAs, and quality issues
• Identify operational risks early and implement mitigation strategies
• Act as escalation 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 Authorities)
• Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs)
• Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, 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:

Qualifications

Education

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (required)
• 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

• Experience managing global or multi-regional Phase I–III trials preferred

Core Competencies & Skills

• Strong understanding of sponsor oversight responsibilities under ICH-GCP
• Hands-on experience 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 multiple studies and vendors simultaneously
• Proficiency with CTMS, eTMF, and clinical systems

Preferred Experience

• Sponsor-side experience in biotech or pharmaceutical companies
• Experience transitioning studies between in-house and outsourced models
• Experience in complex or rare disease trials
• Prior inspection support experience

Travel

Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections