Job description
Prepare and update Annotation List, Data Validation Plan, Edit Check Specifications, and Database/ Data Entry Screens as per study requirements.
Preparation of Operational Manual (EDC Trials)
Prepare CRF Filling Guidelines.
Perform query management activities per study requirements including the manual queries raised by data entry team and medical coder; i.e. query generation and resolution.
Quality Check form updates and reverification.
Filling the data in 2 CRF(s) or data base testing.
Validate the external data after uploading into the database.
SAE and Lab data reconciliation.
Update Self Evident Correction queries in Self Evident Correction Form per study requirements.
Update reports and trackers on regular basis or as per study requirements.




Any other duties as assigned by supervisor or department

Skills and Qualifications:

Knowledge of:
MS Office
Basic knowledge of clinical research
Requirements of Positive Clinical Practices
Requirements of Positive Documentation Practices
Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

Ability to:
Good knowledge of Medical Terminology
Positive communication and writing skills
Work in a team.
Managing work within timelines
Take discission in occupied time schedule.

Experience and Education:
BDS/BAMS/BHMS OR
Diploma in Clinical Research

📌 Validation Associate Faridabad
🏢 JSS Medical Research
📍 Faridabad