[URGENT] Clinical Trial Project Specialist (Phase 1/ Early Phase)
Summary
Coordinate Phase 1 clinical trials, manage timelines and stakeholders, ensure GCP compliance, and support study start-up through close-out.
Responsibilities
Manage clinical trial activities from study start-up through close-out.
Coordinate study implementation, timelines, milestones and deliverables.
Liaise with sponsors, study teams, monitors, ethics committees and external vendors.
Review and coordinate study-related documents and trial materials.
Support study risk assessment and implementation of mitigation plans.
Coordinate site training, study initiation, monitoring and close-out visits.
Lead study meetings and ensure effective communication among stakeholders.
Track study progress and provide regular updates on status, issues and timelines.
Coordinate regulatory and ethics submission requirements.
Support subject safety reporting and follow-up on study-related issues.
Coordinate resolution of protocol, data and monitoring queries.
Maintain accurate and complete clinical trial documentation and records.
Coordinate study supplies, logistics and external vendors.
Support study budget tracking and financial administration.
Ensure study activities comply with GCP, SOPs and applicable regulatory requirements.
Support audits, inspections and quality-related activities.
Contribute to process improvements and study lessons-learned activities.
Support archival and close-out of study documentation.
Travel when required for study-related activities.
Requirements
Diploma or Degree in Nursing, Science, Healthcare, Health Management or related field.
Minimum 5 years of clinical research experience, preferably with Clinical Research Unit / Phase 1 operations.
Strong knowledge of Good Clinical Practice (GCP) and clinical trial processes.
Interested candidates who wish to apply for the advertised position, please send in your updated resume to gs1@talenttradersg.com
EA License No: 13C6305
Reg. No.: R24120209 (GAN CHYE SHEN)
For candidate who applied for the advertised position is deemed to have consented to us that we may collect, use or disclose your personal information for purpose in connection with the services provided by us.