Emerald Clinical Trials, a global full-service Contract Research Organization (CRO), is hiring a Clinical Trial Specialist (CTS) for its Clinical Operations team in Bangalore (Hybrid). This opportunity is ideal for professionals with 2โ3 years of CTS experience seeking career growth in global clinical trials, TMF management, and site start-up operations.
With strong expertise across renal, cardiometabolic, and oncology clinical trials, Emerald Clinical Trials combines global reach with local execution, making it a preferred CRO for innovative biopharmaceutical and medical device research.
Job Overview โ Clinical Trial Specialist
- Job Title: Clinical Trial Specialist (CTS)
- Department: Clinical Operations
- Location: Bangalore, India
- Work Mode: Hybrid
- Employment Type: Full-Time
- Industry: Contract Research Organization (CRO)
Key Responsibilities
As a Clinical Trial Specialist, you will support site start-up, TMF oversight, and clinical trial maintenance activities, ensuring full regulatory compliance.
Core Duties
- Set up, maintain, and quality-check Trial Master Files (TMF) (electronic & hard copy)
- Upload and manage TMF documents within Emerald Clinicalโs systems
- Act as TMF QC reviewer and TMF Lead when assigned
- Support end-of-study TMF reconciliation, QC, and archival
- Assist in audit preparation and inspection responses
- Perform quality control checks on clinical documents and communications
- Support CTMS data entry, tracking, and investigator payment activities
- Coordinate with CRA, CTM, and Project Managers during site start-up
- Manage Essential Document Packets (EDPs) from clinical sites
- Support Local and Central IRB/IEC submissions
- Review Informed Consent Forms (ICFs) (initial and amended)
Eligibility & Qualifications
Mandatory Requirements
- 2โ3 years of experience as a Clinical Trial Specialist (CTS)
- Prior experience in TMF management and site start-up activities
Preferred Qualifications
- Bachelorโs or Masterโs degree in Life Sciences, Pharmacy, Nursing, or Health Sciences
- Knowledge of ICH-GCP, regulatory guidelines, and ethical requirements
- Familiarity with medical terminology and clinical trial documentation
Why Join Emerald Clinical Trials?
Emerald Clinical Trials is committed to people-centric clinical research, offering employees a strong platform for professional development.
Employee Benefits
- Competitive salary aligned with CRO industry standards
- Hybrid working model for better work-life balance
- Global exposure to multinational clinical trials
- Continuous learning and career development programs
- Employee wellbeing initiatives and recognition programs
- Inclusive, equal-opportunity work environment
Salary Range (Indicative)
๐ฐ โน6,50,000 โ โน9,50,000 per annum
(Final compensation depends on experience, skills, and interview performance)
How to Apply
