eTMF Lead - Documentation Excellence & Training

OPIS; Batu Pahat; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading clinical research organization in Malaysia seeks an experienced eTMF Lead to oversee eTMF management. The successful candidate will be responsible for maintaining documentation health, training staff on documentation procedures, and ensuring high-quality compliance standards. Candidates should possess a life science degree, relevant experience in the pharmaceutical or CRO industry, and strong leadership skills. The position offers a competitive salary and benefits package in an innovative environment.

Benefits

Competitive salary and benefits package

Opportunities for growth and innovation

Qualifications

• Minimum 3 years of experience in a similar role in the pharmaceutical or biotechnology sector.
• Experience with electronic databases for document management.
• Strong communication abilities in English.

Responsibilities

• Manage the eTMF as Process Owner, ensuring documentation health.
• Train eTMF Assistant and Specialist on documentation management.
• Contribute to management and development of compliance procedures.

Skills

Fluent English (written and speaking)

Excellent interpersonal skills

Leadership skills

Attention to detail

Problem-solving abilities

Organizational skills

Multitasking

Education

Life science Degree

Tools

MS Office Suite

Document management systems

Job description

A leading clinical research organization in Malaysia seeks an experienced eTMF Lead to oversee eTMF management. The successful candidate will be responsible for maintaining documentation health, training staff on documentation procedures, and ensuring high-quality compliance standards. Candidates should possess a life science degree, relevant experience in the pharmaceutical or CRO industry, and strong leadership skills. The position offers a competitive salary and benefits package in an innovative environment.