Senior Clinical Research Coordinator

About the Company

An established global pharmaceutical and healthcare organization with a strong focus on clinical research and drug development is seeking an experienced Clinical Project Specialist to join its Singapore team.

About the Role

We are looking for an experienced Clinical Project Specialist to manage and coordinate clinical trials from study planning through to completion.

You will serve as the primary point of contact between the clinical research team, pharmaceutical sponsors, investigators and external stakeholders, ensuring that clinical studies are conducted efficiently and in compliance with Good Clinical Practice (GCP) guidelines and relevant regulatory requirements.

This role is ideal for candidates with strong clinical research experience, excellent organisational skills and the ability to manage multiple study activities and stakeholders.

Key Responsibilities

• Manage clinical trial activities from study planning and implementation through to study close-out.

• Coordinate with sponsors, investigators and clinical research teams to ensure smooth study execution.

• Review and coordinate study-related documents, including clinical protocols, informed consent forms and case report forms.

• Coordinate IRB/ERB submissions, protocol amendments and regulatory documentation.

• Monitor study timelines, milestones and deliverables, providing regular updates to sponsors and internal teams.

• Coordinate site initiation, monitoring and close-out visits.

• Manage study documentation and ensure proper maintenance of Investigator Trial Master Files.

• Coordinate the reporting and follow-up of Serious Adverse Events (SAEs) and study deviations.

• Liaise with external vendors, monitors and collaborators.

• Identify and resolve study-related issues that may affect timelines or deliverables.

• Support clinical audits, inspections and continuous improvement initiatives.

• Coordinate study supplies, training requirements and operational arrangements with relevant teams.

Job Requirements

• Diploma or Degree in Nursing, Science or a Health-related discipline.

• Minimum 5 years of clinical research experience.

• Strong knowledge of Good Clinical Practice (GCP) guidelines.

• Experience in clinical trial coordination and study management.

• Familiarity with IRB/ERB submissions, clinical trial documentation and regulatory requirements.

• Excellent organisational and project management skills.

• Strong written and verbal communication skills.

• Good interpersonal and stakeholder management abilities.

• Proficient in Microsoft Office applications.

Preferred Qualifications

• Experience working in a Clinical Research Unit (CRU) or Phase I clinical research environment.

• Experience managing clinical trials from planning through to close-out.

• Previous experience liaising with pharmaceutical sponsors, investigators and clinical trial monitors.

What We Offer

• Opportunity to work with an established global pharmaceutical organisation.

• Exposure to clinical research and drug development.

• Opportunity to collaborate with experienced clinical research professionals.
  

  Business Edge Personnel Services Singapore

  EA License No: 96C4864

  EA Personnel Reg No: R26159908 (Tan Ying Ying)