Clinical Trial Coordinator: TMF & Study Ops Lead

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore is seeking a detail-oriented Clinical Trial Support Specialist to assist sponsor-side teams with TMF/eTMF management, documentation control and regulatory compliance. You will help maintain study files, support CRO oversight, and ensure quality checks.

This role also covers budget tracking, vendor management, CTMS data entry and coordination of study logistics, meetings and trainings.

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• 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.

Skills

TMF/eTMF management

CTMS usage

Clinical documentation

Regulatory compliance

Stakeholder communication

Education

Bachelor's Degree in Life Sciences/Clinical Research

Tools

CTMS

Electronic documentation systems

Job description

Recruit Express Pte Ltd in Singapore is seeking a detail-oriented Clinical Trial Support Specialist to assist sponsor-side teams with TMF/eTMF management, documentation control and regulatory compliance. You will help maintain study files, support CRO oversight, and ensure quality checks.

This role also covers budget tracking, vendor management, CTMS data entry and coordination of study logistics, meetings and trainings.