Local Trial Manager, Clinical Operations Lead

IQVIA Inc; Kuala Lumpur; Sur place; MYR 120 000 - 180 000; Plein temps

Résumé du poste

IQVIA is seeking a Local Trial Manager in Kuala Lumpur to lead the operational delivery of clinical trials at the country level, ensuring adherence to protocol, ICH-GCP, and local regulations while coordinating cross-functional teams.

You will oversee start-up to closeout, monitor recruitment, manage study budgets, and support audits, inspections, and site activities, with travel as required.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Pharmacy, Nursing, or related discipline.
• Minimum 3 years in clinical research, clinical operations, or local trial management.
• Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• 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 and stakeholder management skills.
• Proficiency in Microsoft Office and CTMS.
• Fluent English communication skills, written and verbal.
• Willingness to travel as required.

Responsabilités

• 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.

Connaissances

Life sciences

Regulatory compliance

Project management

Cross-functional coordination

Budget forecasting

Communication skills

Travel readiness

Formation

Bachelor's degree in Life Sciences or related

Outils

Microsoft Office

CTMS

Description du poste

IQVIA is seeking a Local Trial Manager in Kuala Lumpur to lead the operational delivery of clinical trials at the country level, ensuring adherence to protocol, ICH-GCP, and local regulations while coordinating cross-functional teams.

You will oversee start-up to closeout, monitor recruitment, manage study budgets, and support audits, inspections, and site activities, with travel as required.