Local Clinical Trials Manager: Country Lead & Delivery

IQVIA; Kuala Lumpur; Hybrid; MYR 180,000 - 300,000; Full time

Job summary

IQVIA in Malaysia is seeking a Local Trial Manager to lead country-level operational delivery of clinical trials, ensuring compliance with protocol, ICH-GCP, and local regulations. You will oversee study start-up through closeout, coordinating cross-functional teams to meet recruitment targets, timelines, and budgets.

The role requires 3+ years in clinical research or operations, strong project management and risk skills, and fluency in English. Travel may be required as part of responsibilities.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Pharmacy, Nursing, or related field.
• Minimum 3 years of experience in clinical research, clinical operations, local trial management, or related functions.
• Strong knowledge of ICH-GCP guidelines and 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.
• Fluent English communication skills, both written and verbal.
• Willingness to travel as 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.

Skills

Project management

Cross-functional coordination

Risk management

Stakeholder management

Communication skills

Organization

Education

Bachelor's degree in Life Sciences/Health Sciences/Pharmacy/Nursing

Tools

CTMS

Microsoft Office

Microsoft Excel

Job description

IQVIA in Malaysia is seeking a Local Trial Manager to lead country-level operational delivery of clinical trials, ensuring compliance with protocol, ICH-GCP, and local regulations. You will oversee study start-up through closeout, coordinating cross-functional teams to meet recruitment targets, timelines, and budgets.

The role requires 3+ years in clinical research or operations, strong project management and risk skills, and fluency in English. Travel may be required as part of responsibilities.