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About the Role
The Clinical Trial Specialist (CTS) supports clinical trial activities as the in-house site start-up and maintenance specialist. The CTS ensures trials comply with regulations, guidelines, and project plans, working closely with the project team to manage feasibility, coordinate start-up, and handle essential documents for site initiation.
Responsibilities
- Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic.
- Increase proficiency in uploading and maintaining TMF files and folders in the file-sharing system.
- Serve as second reviewer for TMF QC.
- May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.
- Assist with/complete end of study TMF filing, QC and archival.
- Further develop skills in preparing and participating in audit responses.
- Perform QC of work prior to sending out to ensure quality product deliverables.
- Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System.
- Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments.
- Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable.
- Assist with presenting final feasibility results to PM team and/or Sponsor.
- Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).
- Submit final EDPs to sponsor or CTM/PM as required.
Requirements
- College / University diploma / degree; OR at least 1 year related experiences and / or training; OR equivalent combination of education and experience.
- Ability to perform general administrative duties as needed or required.
- Exposure to medical terminology preferred.
- Knowledge of ICH/GCP, ethical and regulatory requirements preferred.
Location
- Singapore
Work Type
- Full-time
Experience Level
- Entry Level
Education Level
- College/University diploma/degree
Benefits
- Competitive Compensation
- Career Growth
- Employee Wellbeing
- Global Opportunities
About the Company
- Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms.
- Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.
- With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.
- Global Expertise. Local Insight. Real Impact.
- Emerald Clinical is where science, speed, and strategy come together to transform healthcare.
- For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.
- Our 800+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide.
- We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.
Equal Opportunity
- We are an equal-opportunity employer and encourage applications from all qualified candidates.