KEY TASKS & RESPONSIBILITIES

- Perform quality control activities (i.e. documentation review, testing) of Biometrics client s Rave EDC and Data management deliverables including eCRFs, Data Validation Specification checks, Custom functions, Data Extracts, Data Integrations, Data Mapping, Custom Data Management Reports and listings
- Participate in the design and development of quality control procedures
- Manage documentation created during the QC process
- Liaise with study teams and other staff to fulfill job responsibilities and activities
- Develop and lead execution of training and knowledge transfer opportunities for quality control team
- Inform the Manager of training issues, project activities, quality issues and timelines as directed
- Collaborate with the project team to ensure the deliverables are completed on time with high quality
- Other duties as assigned

CANDIDATE S PROFILE

Education/Language:

- Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field)
- Excellent knowledge of English

Skilled Skills & Experience

- Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent




- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred
- Experience performing quality control activities of clinical trial deliverables preferred
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent team player

Technical Skills & Experience

- Extensive knowledge of Medidata Rave EDC platform and other modules of Rave preferred
- Familiarity with Databases: SQL Server, Oracle highly preferred
- Extensive validation experience of eCRFs, Edit Checks, Custom Functions, Data Management

reports and good understanding of Database structures and Programming languages

- Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint

Skills: Oracle Database, medidata , Programming Languages, Sql Sever, Data Management, Quality Control, Pharmaceutical

Experience: 3.00-5.00 Years

📌 QC Specialist (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru