Clinical Trial Specialist

3 days ago

Petaling Jaya, Selangor, Malaysia George Clinical Pty Full time

Join to apply for the Clinical Trial Specialist role at George Clinical.

At George Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology—areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need.

Why Join Us?

At our core, George Clinical is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you'll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here's what makes us stand out:

  1. Purpose-Driven Work: You'll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
  2. Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
  3. Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

About the Role

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. They support the project manager, clinical trial manager and clinical operations management related to the project startup, maintenance, and close-out activities in specified administrative functions including Trial Master File set-up and maintenance.

Your Responsibilities

  • Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project.
  • Increase proficiency in uploading and maintaining TMF files and folders in George Clinical's file-sharing system by project as assigned.
  • Serve as second reviewer for TMF QC.
  • May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.
  • Assist with/complete end of study TMF filing (including site close out documents), QC and archival.
  • Further develop skills in preparing and participating in audit responses.
  • Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables.
  • Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.
  • Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.
  • Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable.
  • Supports site staff in the submission to Central IRBs/ECs, performs review of ICFs (initial and updated) and submits on behalf of sites (if applicable).
  • Conducts all assigned tasks and adheres to company SOPs/guidelines, IRB requirements, project plans, ICH/GCP and other federal and regulatory guidelines.

About You

  • Tertiary qualifications in a related science or health care discipline OR previous clinical research experience preferred.
  • Ability to perform general administrative duties as needed or required.
  • Exposure to medical terminology and physiology preferred.
  • Exposure to ICH/GCP, ethical and regulatory requirements preferred.
  • Good organizational skills and attention to detail required to manage daily tasks.

What We Offer

We understand that great work happens when people feel valued and supported. That's why we provide:

  1. Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
  2. Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
  3. Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
  4. Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
  5. Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.

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