Description
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.
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.
- Fluent English communication skills, both written and verbal.
- Willingness to travel as required.