Position Overview
The Clinical Data Specialist is responsible for ensuring accurate and timely data entry, query resolution, and maintenance of clinical trial data within CTMS and Electronic Data Capture (EDC) systems. This position plays a key role in supporting integrity, quality, and regulatory compliance of clinical data throughout the study lifecycle. The ideal candidate is experienced, detail-oriented, and collaborative, with a solid background in clinical data management and/or clinical trial coordination.
Key Responsibilities
- Perform quality control measures on source documentation including use of CTMS and transfer data to Electronic Data Capture (EDC) systems, such as RAVE, Veeva Vault, Clinical One, or Inform.
- Verify that source documents adhere to ALCOA-C guidelines and ensure EDC data entries are accurate and consistent with source documentation.
- Identify need for corrections and resolve data discrepancies or queries in a timely and effective manner.
- Ensure compliance with clinical protocols, GCP, ALOCA-C, HIPAA, and other regulatory guidelines.
- Participate in ongoing quality control and data validation processes to maintain high standards of data integrity.
- Collaborate with cross-functional teams to review source documents, case report forms (eCRFs), lab manuals, and related clinical documentation.
- Assist in the preparation and review of study-related documents, including protocols, lab manuals, CRF completion guidelines, and other study resources.
- Support audit readiness by participating in internal quality reviews and maintaining proper documentation.
- Develop comprehensive source documents directly from clinical trial protocols, lab manuals, and eCRF guidelines aligning with regulatory standards and study requirements
- Provide recommendations for corrective actions and escalate when data issues or protocol deviations are identified.
- Contribute to the organization and coordination of data management tasks as needed.
Qualifications and Experience
- 3 years of experience as a Clinical Research Coordinator of complex interventional trials or performing clinical data management for clinical research sites.
- Competent working within CTMS CRIO and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform.
- Strong understanding of clinical protocols, CRF completion guidelines, clinical data management process, and regulatory requirements.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Strong attention to detail, organizational skills, and the ability to manage multiple priorities.
- Willingness to work a schedule which aligns with the company’s US operating hours.
Job Type: Full-time
Benefits:
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund
- Work from home
Ability to commute/relocate:
- Sholinganallur, Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Required)
Education:
Experience:
- Clinical research coordinator: 3 years (Required)
Work Location: Hybrid remote in Sholinganallur, Chennai, Tamil Nadu
