Job Location: India
Accountabilities: Demonstrates full competence when conducting the following tasks
- Development of database build specifications
- Development of data validation specifications
- Test data creation & UAT
- Performing/ leading functional QC activities and testing
- Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
- Data validation and cleaning
- Conduct medical coding if assigned
- Conduct SAE & third party data reconciliations
- Perform early and final database QC activities
- Database lock activities
- Maintaining Clinical Study Documents and archiving as appropriate
- Responsible for completeness, timely delivery and quality of clinical data
- Learning role of Primary CDA
- Act as a single point of contact (internal expert) for specific processing task(s) on a project
- Support site monitoring personnel to retrieve missing data as required
- Other assigned responsibilities as needed Skills
- Strong interpersonal, verbal and written communication skills
- Strong technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office products
- Good awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
- Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
- Seeks opportunities to develop experience and knowledge in Clinical Trials and Pharmaceutical Industry
- Ability to plan tasks and complete them within the appropriate timescale and to the required quality
- Ability to work in team environment.
- Commitment and performs consistently high quality work Education
Qualifications
- Bachelor’s degree and / or other medical qualification or relevant DM experience Language Skills
- Competent in written and oral English. Excellence in regional languages as needed. Minimum Work Experience
- Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required
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