eTMF Lead

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

Overview

The eTMF Lead, in compliance with the applicable procedures, is mainly responsible for the eTMF management, as Process Owner, with the aim of maintaining in good health the documentation archived in the system. Acts as responsible for training both eTMF Assistant and eTMF Specialist on documentation management and archiving procedures to ensure high documents quality standards. Contributes to the management and development of procedures relating to the activities in which is involved, ensuring that the activities of the whole Unit meet the quality standards required by the company.

What we’re looking for

• Life science Degree
• Previous experience in similar role (at least 3 years) in the pharmaceutical, biotechnology, CRO industry
• Familiarity with document management systems and electronic databases
• Fluent English (written and speaking)
• Proficiency in MS Office Suite and other relevant software
• Excellent interpersonal, leadership and communication skills
• Exceptional attention to detail, accuracy and organizational skills
• Ability to multitask, prioritize work and meet deadlines
• Result/Team-working oriented
• Strong problem-solving and decision-making abilities

What we offer

We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth, innovation, and customer success.

Please read the information notice on the processing of personal data in the candidates’ information section of our company website.

Who we are

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.