Validation Associate

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. Masters in any branch of Life science or pharmaceuticals and
3. Diploma in Clinical Research