Validation Associate

JSS Medical Research; Faridabad District; On-site; INR 300,000 - 540,000; Full time

Job summary

JSS Medical Research in Faridabad, Haryana, is seeking a capable data management associate to support annotation lists, data validation plans, and database screens for clinical studies.

You're expected to prepare CRF guidelines, manage queries, perform QA checks, and reconcile SAE/lab data while maintaining timelines and team collaboration. Diploma in Clinical Research or BDS/BAMS/BHMS is preferred.

Qualifications

• MS Office and basic clinical research knowledge.
• Knowledge of GCP and GDP for documentation and trials.
• FDA 21 CFR Part 11 requirements for electronic records handling.
• Good communication and writing skills.
• Ability to work in a team and manage timelines.

Responsibilities

• Prepare and update Annotation List, Data Validation Plan, Edit Check Specifications, and Database/Data Entry Screens.
• Prepare Operational Manual (EDC Trials).
• Prepare CRF Filling Guidelines.
• Perform query management with manual queries from data entry and medical coding.
• Quality Check form updates and reverification.
• Fill data in 2 CRF(s) or data base testing.
• Validate external data after uploading into the database.
• SAE and Lab data reconciliation.
• Update Self Evident Correction queries as per study requirements.
• Update reports and trackers regularly or as required.
• Any other duties as assigned by supervisor or department.

Skills

MS Office

Clinical research knowledge

GCP knowledge

GDP knowledge

FDA 21 CFR Part 11

Education

BDS/BAMS/BHMS

Diploma in Clinical Research

Job description

Job description

1. Prepare and update Annotation List, Data Validation Plan, Edit Check Specifications, and Database/ Data Entry Screens as per study requirements.
2. Preparation of Operational Manual (EDC Trials)
3. Prepare CRF Filling Guidelines.
4. 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.
5. Quality Check form updates and reverification.
6. Filling the data in 2 CRF(s) or data base testing.
7. Validate the external data after uploading into the database.
8. SAE and Lab data reconciliation.
9. Update Self Evident Correction queries in Self Evident Correction Form per study requirements.
10. Update reports and trackers on regular basis or as per study requirements.
11. Any other duties as assigned by supervisor or department

Skills and Qualifications:

Knowledge of:

1. MS Office
2. Basic knowledge of clinical research
3. Requirements of Good Clinical Practices
4. Requirements of Good Documentation Practices
5. Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

Ability to:

1. Good knowledge of Medical Terminology
2. Good communication and writing skills
3. Work in a team.
4. Managing work within timelines
5. Take discission in occupied time schedule.

Experience and Education:

1. BDS/BAMS/BHMS OR
2. Diploma in Clinical Research