Senior Clinical Start-Up Lead

AstraZeneca; Selangor; On-site; MYR 204,000 - 287,000; Full time

Job summary

A leading pharmaceutical company is seeking a Study Start-Up Manager in Selangor, Malaysia. The role includes managing start-up activities for clinical studies, ensuring compliance with regulations, and working with local study teams. The ideal candidate will have a Bachelor’s degree in life sciences and excellent communication and negotiation skills. This position requires strong attention to detail and the ability to work collaboratively in a dynamic environment. Apply now to contribute to innovative healthcare solutions.

Qualifications

• Good knowledge of international guidelines ICHGCP and local regulations.
• Basic understanding of drug development process.
• Excellent understanding of Clinical Study Management and study start-up.

Responsibilities

• Manage start-up activities in compliance with AZ procedures.
• Prepare and track site regulatory documentation.
• Ensure timely collection of essential documents in the eTMF.

Skills

Good collaboration and interpersonal skills

Good verbal and written communication skills

Excellent attention to details

Good negotiation skills

Education

Bachelor's degree in related discipline, preferably in life science

Job description

A leading pharmaceutical company is seeking a Study Start-Up Manager in Selangor, Malaysia. The role includes managing start-up activities for clinical studies, ensuring compliance with regulations, and working with local study teams. The ideal candidate will have a Bachelor’s degree in life sciences and excellent communication and negotiation skills. This position requires strong attention to detail and the ability to work collaboratively in a dynamic environment. Apply now to contribute to innovative healthcare solutions.