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Clinical Trial Associate | R&D Department - # HJZ
Looking to grow your career in clinical research? Join our MNC in supporting clinical project teams in the coordination and administration of clinical trials. This role offers hands-on exposure to Trial Master File (TMF) management, clinical study documentation, budget tracking and CRO oversight!
Job Responsibilities
Trial Master File (TMF) & Documentation
- Set up, maintain and archive electronic Trial Master Files (eTMF).
- Ensure timely filing, review, approval and quality checks of essential clinical trial documents.
- Support CRO oversight by developing eTMF guidelines and establishing document review processes.
- Ensure study documentation complies with Good Clinical Practice (GCP), internal SOPs and applicable regulatory requirements.
Clinical Study & Project Support
- Provide administrative and operational support to Clinical Project Managers (CPMs) and study teams.
- Maintain clinical study management tools, trackers and databases.
- Assist with clinical trial registration on ClinicalTrials.gov.
- Support quality checks of study protocols, informed consent forms and advertising materials.
- Assist with clinical study budget tracking, invoice management and payment processing.
- Support vendor creation, goods receipt checks and invoice uploads into finance systems.
- Monitor monthly budget commitments and actual study expenditure.
Logistics & Coordination
- Coordinate clinical trial logistics, including sample and ancillary shipments, procurement of study supplies and training arrangements.
- Organise internal clinical meetings, CRO meetings and investigator meetings, including preparation of agendas, minutes and logistics.
- Assist with global communications, newsletters, emails and website updates.
- Support the preparation and maintenance of SOPs, work instructions, training materials and templates.
- Contribute to continuous process improvement initiatives, including CTMS data entry and SOP revisions.
Requirements
- Minimum Bachelor's Degree in Life Sciences, Biomedical Science, Clinical Research, Pharmacy or a related discipline.
- Minimum 2 years of clinical trial experience on the sponsor side.
- Strong hands-on experience in Trial Master File (TMF/eTMF) management is highly preferred.
- Good understanding of ICH-GCP guidelines, clinical trial documentation and regulatory requirements.
- Experience supporting Clinical Project Managers and coordinating clinical study activities.
- Familiarity with clinical trial management systems (CTMS) and electronic documentation systems.
- Strong organisational, documentation and communication skills.
- Meticulous, detail-oriented and able to manage multiple study-related tasks and deadlines.
Jenny Ng Zhern IngOutsourcing TeamRecruit Express Pte LtdCompany Reg. No. 199601303W | EA License Number: 99C4599
We regret to inform that only suitable candidates will be shortlisted for an interview.