Clinical Trial Manager

Clinovo; Argentina; On-site; ARS 2,000,000 - 3,000,000; Full time

Job summary

Clinovo is seeking an experienced Clinical Trial Manager (CTM) to provide sponsor-side oversight of outsourced clinical trials managed by CROs. The CTM will ensure CRO partners execute studies on time, within budget, and in compliance with protocols and regulatory requirements.

The role emphasizes CRO governance, performance monitoring, risk mitigation, and cross-functional collaboration to support study initiation, enrollment, data quality, and closeout across Phase I–III trials.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field required.
• Advanced degree preferred.
• 5–8 years in clinical research or CRO industry.
• 3+ years in clinical trial management, sponsor-side preferred.
• Experience overseeing CRO partners and outsourced trials.

Responsibilities

• Oversee CRO partners delivering Phase I–III trials, ensuring adherence to protocols, timelines, budgets, and quality standards.
• Manage sponsor-oversight of study deliverables, site activation, enrollment, monitoring, data quality, and closeout.
• Govern CRO performance via governance structures, KPIs, reviews, and escalation procedures.
• Collaborate with internal functions and external vendors to maintain inspection readiness and risk-based monitoring.

Job description

We are seeking an experienced Clinical Trial Manager (CTM) to provide sponsor-side oversight of outsourced clinical trials managed by Contract Research Organizations (CROs). The CTM will be responsible for ensuring CRO partners execute clinical studies in accordance with established timelines, budgets, quality standards, protocols, and applicable regulatory requirements.

The ideal candidate will have extensive experience managing CRO relationships, overseeing clinical trial deliverables, identifying and mitigating operational risks, and ensuring accountability across outsourced clinical programs.

This individual will serve as the primary operational liaison between the sponsor and CRO partners, providing strategic oversight while maintaining visibility into study execution, site performance, patient enrollment, data quality, and overall study progress.

Key Responsibilities

CRO Management and Oversight

• Serve as the primary sponsor-side point of contact for CRO partners responsible for clinical trial execution.
• Provide comprehensive oversight of CRO activities to ensure alignment with study objectives, timelines, budgets, and contractual obligations.
• Establish and maintain CRO governance structures, including regular operational meetings, performance reviews, and escalation procedures.
• Monitor CRO performance against established key performance indicators (KPIs), milestones, and contractual deliverables.
• Review CRO project plans, study timelines, monitoring plans, and operational strategies to ensure appropriate execution.
• Proactively identify CRO performance gaps, operational challenges, and potential delays, implementing corrective action plans when necessary.
• Ensure CRO accountability for study deliverables, including site activation, enrollment, monitoring, data management, and study closeout.
• Lead issue escalation and resolution activities involving CRO leadership and sponsor stakeholders.

Clinical Trial Operations

• Provide operational oversight of Phase I-III clinical trials, ensuring compliance with approved protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Oversee clinical trial activities from study startup through execution, database lock, and closeout.
• Monitor study progress, including site initiation, enrollment, patient retention, monitoring activities, and data cleaning.
• Review CRO-generated study status reports, dashboards, and operational metrics to identify trends and potential risks.
• Ensure appropriate oversight of site monitoring activities, including monitoring visit compliance, outstanding action items, and site performance.
• Collaborate with CRO teams to address enrollment challenges, protocol deviations, site issues, and study execution risks.
• Maintain sponsor-level oversight of clinical trial documentation and inspection readiness.
• Support development and implementation of risk-based monitoring and quality management strategies.

Vendor Performance and Quality Management

• Oversee CRO compliance with contractual obligations, service-level agreements, and study-specific performance expectations.
• Establish and track operational KPIs related to site activation, enrollment, monitoring compliance, data quality, and milestone achievement.
• Review and evaluate CRO performance reports and identify opportunities for process improvement.
• Ensure timely identification, documentation, escalation, and resolution of quality issues, protocol deviations, and operational risks.
• Partner with Clinical Quality Assurance to support vendor audits, inspection readiness, and corrective and preventive action (CAPA) activities.
• Ensure appropriate sponsor oversight documentation is maintained throughout the clinical trial lifecycle.
• Coordinate oversight of additional clinical vendors, including central laboratories, imaging providers, eCOA vendors, and other service providers, as applicable.

Study Timeline and Budget Oversight

• Maintain oversight of integrated study timelines, critical milestones, and CRO deliverables.
• Identify potential timeline risks and work collaboratively with CRO partners to develop mitigation and recovery plans.
• Review CRO budgets, forecasts, change orders, and invoices to ensure alignment with approved study budgets and contracted services.
• Monitor study financial performance and elevate budget variances or potential scope changes.
• Partner with internal stakeholders to evaluate CRO resource allocation and operational efficiency.
• Ensure CRO staffing levels and resource plans are appropriate to support study execution and timelines.

Cross-Functional Collaboration

• Collaborate with internal Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Quality Assurance teams.
• Facilitate cross-functional communication between sponsor stakeholders and CRO project teams.
• Lead or participate in study governance meetings, operational reviews, and cross-functional planning discussions.
• Provide regular study updates to Clinical Operations leadership, including progress against milestones, emerging risks, and CRO performance.
• Support clinical development planning and operational strategy for current and upcoming clinical programs.

Qualifications

Education

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline required.
• Advanced degree preferred.

Required Experience

• Minimum of 5–8 years of clinical research experience within the pharmaceutical, biotechnology, or CRO industry.
• At least 3 years of clinical trial management experience, preferably in a sponsor-side role.
• Demonstrated experience directly overseeing CRO partners responsible for outsourced clinical trial execution.
• Experience managing clinical trials across multiple phases of development, preferably Phase II and Phase III.
• Strong understanding of CRO governance, vendor performance management, and sponsor oversight responsibilities.
• Experience managing study timelines, clinical trial budgets, CRO deliverables, and operational risks.
• Working knowledge of ICH-GCP, FDA regulations, and applicable global clinical trial requirements.
• Experience reviewing clinical trial operational metrics, monitoring reports, enrollment dashboards, and vendor performance indicators.
• Demonstrated ability to manage CRO performance issues and drive corrective actions.
• Experience collaborating with cross-functional clinical development teams.

Preferred Qualifications

• Prior experience working within a biotechnology or pharmaceutical sponsor organization overseeing fully outsourced clinical trials.
• Experience managing global or multicenter clinical studies.
• Experience overseeing multiple CROs or specialized clinical service providers.
• Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), electronic data capture (EDC), and clinical trial reporting dashboards.
• Experience supporting regulatory inspections, sponsor audits, and clinical quality management activities.
• Experience transitioning studies between CRO partners or supporting CRO selection and vendor qualification.
• Therapeutic area experience in oncology, rare diseases, immunology, or other complex clinical development programs.