Senior Clinical Research Associate

PSI CRO AG; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in clinical research is seeking a Senior CRA in Malaysia to manage clinical trials. The role involves supervising study activities, ensuring compliance with industry standards, and maintaining communication with project stakeholders. Ideal candidates should have a Bachelor's degree in Life Sciences or related fields and substantial monitoring experience.

Benefits

Opportunities for growth through on-the-job learning

Formal development programs

Qualifications

• 4-5 years of independent on-site monitoring experience.
• Experience in monitoring Phase II and/or III clinical trials.
• Experience in Oncology or Hematology is a significant advantage.

Responsibilities

• Supervise study activities, timelines, milestones, and schedules.
• Conduct and report all types of onsite monitoring visits.
• Manage communication with and oversight of study sites.

Skills

Communication

Problem-solving

Team collaboration

Planning

Multitasking

Education

Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing

Job description

We are the company that cares – for our staff, for our clients, for our partners, and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business involves conducting clinical research of novel medications. We operate at the interface of R&D, the pharmaceutical industry, and healthcare science, providing services to large and mid-sized pharmaceutical companies. We help our clients generate data on drug safety and efficacy, bringing the best medications to market. Through global clinical trials, PSI makes cutting-edge treatments available worldwide and helps patients with serious medical conditions improve or even save their lives. Help us ensure that PSI's medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

Our story is one of organic growth from a handful of countries to a global presence. PSI is a mature company with established standards and practices, yet we continuously evolve. Every day presents new challenges, and you will not find yourself bored here.

Job Description

We are seeking a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI, you will be the primary communication link with project stakeholders, ensuring the successful conduct of clinical trials across various therapeutic areas. You will maintain the highest industry standards while performing and supervising study start-up, clinical monitoring, and site management activities at the country and regional levels.

You will be among our first team members in Malaysia and will contribute to the development of PSI Operations. The candidate can be based anywhere in Malaysia.

You will:

• Supervise study activities, timelines, milestones, and schedules at the country level.
• Conduct and report all types of onsite monitoring visits.
• Participate in study setup, including site contract and budget negotiations.
• Manage communication with and oversight of study sites.
• Ensure consistency of study processes and identify country-specific differences.
• Oversee maintenance of study-specific and corporate tracking systems.
• Contribute to the development and updating of project planning documents, essential documents, and instructions.
• Serve as a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
• Oversee clinical trial country submissions and approvals for assigned protocols.
• Develop local language materials, including informed consents and translations.
• Coordinate with IRB/IEC and Regulatory Authorities for submission and approval processes.

Qualifications

The ideal candidate must possess the following qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Registered Nursing, or equivalent; registered pharmacists are strongly preferred.
• At least 4-5 years of independent on-site monitoring experience or equivalent expertise.
• Extensive experience in monitoring Phase II and/or III clinical trials.
• Feasibility assessment and study setup experience is highly desirable.
• Experience in Oncology or Hematology is a significant advantage.
• Effective planning, multitasking, and team collaboration skills.
• Excellent communication, problem-solving, and interpersonal skills.
• Willingness and ability to travel extensively within Malaysia.

Additional Information

What makes us different?

PSI is privately owned by its founders, who are still actively involved. This independence allows us to grow organically and maintain our core values. We invest heavily in our people, offering opportunities for growth through on-the-job learning and formal development programs, from entry-level to senior leadership roles.