# Local Trial Manager

**Company**: IQVIA
**Location**: Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Wilayah-Persekutuan-Kuala-Lumpur-Malaysia/Clinical-Lead-Local-Trial-Manager_R1544974?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c5e657a5-921

## 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.

## Skills

### Required
- ICH-GCP guidelines
- clinical trial management
- project management
- risk management
- budget management
- forecasting
- Microsoft Office
- English

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Wilayah-Persekutuan-Kuala-Lumpur-Malaysia/Clinical-Lead-Local-Trial-Manager_R1544974?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
