Local Trial Manager

The Local Trial Manager is responsible for leading the operational delivery of clinical trials at the country level, ensuring studies are conducted in compliance with protocol requirements, ICH-GCP guidelines, applicable regulations, and internal processes. This role provides oversight from study start-up through closeout activities, partnering with cross-functional stakeholders to deliver high-quality data, maintain inspection readiness, and achieve study timelines, enrolment targets, and budget commitments. The Local Trial Manager serves as the primary country-level contact for assigned studies and may support site monitoring activities when required.

Responsibilities:

• Lead country-level operational delivery of assigned clinical trials from study start-up through closeout activities.
• Serve as the primary point of contact for assigned studies and coordinate activities across cross-functional teams.
• Drive study execution to achieve recruitment targets, timelines, quality standards, and budget commitments.
• Support site identification, feasibility assessments, qualification activities, and site selection decisions.
• Lead local study team activities, risk management, and implementation of study-specific processes.
• Monitor study progress, analyze operational metrics, and implement corrective actions as required.
• Ensure inspection readiness by maintaining complete and accurate trial documentation and essential records.
• Manage study vendors and country-level services, including oversight of deliverables and invoices.
• Ensure compliance with applicable regulatory requirements, ethics committee approvals, and safety reporting obligations.
• Oversee study budgets, forecasting, financial tracking, and support site contract negotiations.
• Support audits and inspections and ensure timely resolution of quality findings.
• Facilitate investigator meetings, study team meetings, and training activities.

Requirements:

• Bachelor's degree in Life Sciences, Health Sciences, Pharmacy, Nursing, or a related discipline.
• Minimum 3 years of experience in clinical research, clinical operations, local trial management, or related functions.
• Strong knowledge of ICH-GCP guidelines and applicable local regulatory requirements.
• Demonstrated experience coordinating cross-functional teams and stakeholders.
• Excellent project management, planning, and risk management skills.
• Experience in study start-up, site management, and closeout activities.
• Strong financial acumen with budget management and forecasting experience.
• Excellent communication, stakeholder management, and interpersonal skills.
• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Office and clinical trial management systems.