Global Study Start-Up Expert

IQVIA LLC; Kuala Lumpur; On-site; MYR 180,000 - 260,000; Full time

Job summary

IQVIA LLC is seeking a highly organized study start-up specialist to support global clinical trials in Malaysia. You will manage feasibility, site identification, CDA handling, and regulatory submissions, ensuring timely project progress.

The role requires 3 years of clinical research experience, strong GCP/ICH knowledge, and excellent negotiation and communication abilities to collaborate with cross-functional teams and external sites.

Qualifications

• Bachelor’s Degree in life sciences or a related field with 3 years’ clinical research experience.
• Deep knowledge of clinical systems, procedures, and corporate standards.
• Strong negotiating and communication skills.
• Effective communication and organizational abilities.
• Ability to work independently and prioritize tasks.
• Knowledge of GCP/ICH and regulatory guidelines.
• Understanding of the regulated clinical trial environment.
• Ability to establish and maintain relationships with coworkers, managers and clients.

Responsibilities

• Coordinate feasibility, site identification, and start-up activities.
• Distribute and collect CDAs for potential sites.
• Provide country-specific start-up expertise to teams.
• Create study start-up document templates.
• Coordinate regulatory submissions and ethics documentation.
• Develop and review SIS/ICFs and translate labels as needed.
• Perform data entry in CTMS for start-up activities.
• Negotiate site contracts and track approvals.
• Attend study team meetings and maintain submission information.

Skills

Negotiation

Communication

GCP/ICH knowledge

Independent worker

Regulatory knowledge

Life sciences background

Education

Bachelor’s Degree in life sciences or related field

Job description

IQVIA LLC is seeking a highly organized study start-up specialist to support global clinical trials in Malaysia. You will manage feasibility, site identification, CDA handling, and regulatory submissions, ensuring timely project progress.

The role requires 3 years of clinical research experience, strong GCP/ICH knowledge, and excellent negotiation and communication abilities to collaborate with cross-functional teams and external sites.