Clinical Trial Operations Specialist

Recruit Express Pte Ltd; Singapore; On-site; SGD 42,000 - 66,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore seeks a clinical study administrator to manage TMF/eTMF, archive documents, and ensure regulatory compliance with GCP and SOPs. You will provide administrative and operational support to Clinical Project Managers, maintain trackers and CTMS, assist with ClinicalTrials.gov registrations and quality checks of study materials, and help oversee budgets and vendors.

This role requires strong organizational skills, attention to detail, and effective collaboration

Qualifications

• Minimum diploma or bachelor degree in Life Sciences or related field.
• ≥2 years of sponsor-side clinical trial experience.
• Strong TMF/eTMF management experience.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Experience supporting Clinical Project Managers and coordinating activities.
• Familiarity with CTMS and electronic documentation systems.
• Strong organizational and communication skills.
• Meticulous, detail-oriented with ability to manage 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

Attention to detail

Documentation

Communication

Coordination

Education

Bachelor's / Diploma in Life Sciences or related field

Tools

CTMS

eTMF systems

Regulatory databases

Job description

Recruit Express Pte Ltd in Singapore seeks a clinical study administrator to manage TMF/eTMF, archive documents, and ensure regulatory compliance with GCP and SOPs. You will provide administrative and operational support to Clinical Project Managers, maintain trackers and CTMS, assist with ClinicalTrials.gov registrations and quality checks of study materials, and help oversee budgets and vendors.

This role requires strong organizational skills, attention to detail, and effective collaboration