Clinical Trial Assistant | MNC Environment - #HJZ

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. Budget & Vendor Management • 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 Diploma or 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. • 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. All interested candidates are invited to email your resume in MS Word format to: Jenny.ng@recruitexpress.com.sg Jenny Ng Zhern Ing Outsourcing Team Recruit Express Pte Ltd Company Reg. No. 199601303W | EA License Number: 99C4599 We regret to inform that only suitable candidates will be shortlisted for an interview.