Clinical Trial Associate (MNC)
RM 5,000 - RM 7,000 / month
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Job Description
Initiate Investigator Site Activities
- Collected and submitted regulatory documents.
- Customized and negotiated informed consent documents.
- Served as the point of contact for the site's ethics review board (ERB) and regulatory authority (RA).
- Communicated and negotiated budgets with site personnel and internal teams.
- Negotiated and obtained fully executed contracts.
- Tracked and ensured site compliance with required training.
- Effectively drove timelines aligned with company priorities.
Collaboration and Communication
- Maintained active collaboration with sites during start-up, maintenance, and close-out phases.
- Acted as a subject matter expert on Trial Capabilities topics.
- Provided oversight, coaching, and technical support to Associates managing high-priority and complex clinical trials.
Regulatory and Data Privacy Compliance
- Ensured country-specific regulatory and data privacy requirements were incorporated into submission documents and other systems.
Clinical Trial Material Management
- Coordinated the management and delivery of clinical trial materials to support site initiation.
- Oversaw the translation process for clinical trial documents and ensured translation quality.
Continuous Improvement and Strategic Use of Systems
- Provided feedback and shared learnings for continuous improvement.
- Utilized internal clinical trial systems (e.g., Vault Clinical, Shared Investigator Platform) for tracking, performance metrics reporting, and regulatory compliance.
- Ensured complete, accurate, and timely documentation and filing in the electronic Trial Master File (eTMF).
- Executed submission and site activation strategies per global team priorities.
- Identified gaps and drove continuous improvement efforts on Trial Capabilities processes and application/system usability.
Requirements
- Bachelor’s degree, preferably in a scientific or health-related field
- At least 3 years of clinical research experience or relevant experience preferred
- Applicant with the understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applicant with knowledge of project management processes and skills
- Applicants with experience in compliance-driven environment is good
- Excellent English language skills (comprehension, speaking, reading, and writing)
- Effective communication and problem-solving skills
- Good organization and time management skills
For those who have what it takes, please apply online or send in your profile to:
Consultant: Wei Li
Tel: 03-7954 8440
For more job opportunities, please visit:
www.brightprospect.com.my/Job_Listing.php
OUR SERVICE FOR JOB SEEKER IS FREE!
Job Type: Full-time
Pay: RM5,000.00 - RM7,000.00 per month
Benefits:
- Health insurance
Schedule:
- Monday to Friday
Supplemental Pay:
- 13th month salary
- Performance bonus