11 Nov
|
Veramed
|
Bengaluru
Purpose
We are looking for Clinical Data Coordinator I with 2 years of experience, this role provides support to the Data Management team during the conduct phase of clinical studies, ensuring data quality, timely query resolution, and productive data review activities in compliance with study requirements and applicable regulations.
Key Responsibilities
Technical Responsibilities
- Review clinical trial data captured in Electronic Data Capture (EDC) systems to ensure completeness, accuracy, and consistency.
- Perform routine data cleaning activities according to Data Management Plans and study guidelines.
- Raise and track data queries with investigational sites and clinical monitors.
- Resolve standard data queries in collaboration with study teams.
- Review data listings and reports to identify discrepancies and missing data.
- Support reconciliation of external vendor data, such as laboratory, ECG, imaging, and ePRO/eCOA data.
- Perform medical coding activities using MedDRA and WHO Drug dictionaries, where applicable.
- Assist with query management metrics and tracking activities.
- Ensure study data is reviewed and maintained in accordance with study timelines.
- Maintain study documentation and files as required.
- Follow internal SOPs, sponsor requirements, GCP, and regulatory guidelines.
- Support audit and inspection readiness activities by maintaining accurate documentation.
- Participate in study status and data review meetings.
- Communicate data issues and risks to the Data Management team in a timely manner.
- Collaborate with Clinical Operations, Biostatistics, Programming, and external vendors as required.
- Escalate data-related issues that may impact study timelines or data quality.
- Support database lock activities by ensuring assigned tasks are completed on time.
Key Skills Required
- Only 2 years of hands-on experience as Clinical Data Coordinator (CDC I)
- EDC Systems (Medidata Rave, Oracle InForm, Veeva CDB, or equivalent)
- Data Cleaning and Query Management
- Data Review Listings
- Medical Coding (MedDRA, WHO Drug)
- External Vendor Data Reconciliation
- GCP and ICH Guidelines
- Attention to Detail and Quality Focus
- Study Conduct Support
- Effective Communication and Team Collaboration
📌 Clinical Data Coordinator I (Bengaluru)
🏢 Veramed
📍 Bengaluru