Clinical Research Associate: Start-Up & Regulatory Lead

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Kuala Lumpur; Presencial; MYR 120 000 - 180 000; Tempo integral

Resumo da oferta

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Kuala Lumpur is seeking a Clinical Research Associate to support Global Clinical Operations.

You will coordinate site regulatory submissions, manage essential documents, and collaborate with clinical sites to ensure timely IRB/EC approvals and documentation readiness. The role requires 2–3 years in clinical research, strong communication, and the ability to work independently within a team.

Qualificações

• Degree in a relevant scientific/healthcare subject or equivalent industry experience.
• 2–3 years of clinical research experience as a Research Coordinator or CRA/Study Start-up Specialist.
• Familiarity with clinical trial management systems (Siebel CTMS, Veeva) and eTMF/document control tools.
• Strong communication and the ability to work independently and in a team.

Responsabilidades

• Coordinate and lead regulatory submissions and essential document collection for trials across start-up, enrollment, follow-up and closure.
• Document management across several studies and ensure regulatory readiness.
• Collaborate with sites to customize informed consent forms and align with business objectives.
• Build relationships with internal customers and clinical sites to become a subject matter expert in start-up regulatory processes.
• Assist with submission processes to meet IRB/EC timelines and mitigate start-up challenges.
• Prepare, complete and track regulatory, ICF and legal documentation.

Conhecimentos

Clinical trial coordination

Communication skills

Independent and team work

Problem solving

Formação académica

Bachelor's degree in life sciences

Ferramentas

Siebel CTMS

Veeva

Descrição da oferta de emprego

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Kuala Lumpur is seeking a Clinical Research Associate to support Global Clinical Operations.

You will coordinate site regulatory submissions, manage essential documents, and collaborate with clinical sites to ensure timely IRB/EC approvals and documentation readiness. The role requires 2–3 years in clinical research, strong communication, and the ability to work independently within a team.