The role of the Clinical Data Coder II (CDC II) is to perform assigned tasks or activities in clinical data coding. Activities may include user acceptance testing (UAT), coding, data validation, generation and integration of queries, running of reports.
To include database set-up through to database lock on assigned projects and with minimal direction / supervision. Undertakes the Principal CDC role on designated studies.
All tasks should be performed in accordance to corporate quality standards, SOPs / Work Instruction / Guidelines, ICH-GCP and / or other international regulatory requirements.
Strong interpersonal, verbal and written communication skills
Strong technical skills including but not limited to the knowledge of Clinical Trial / Data Management / Coding Systems, PMED, 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
Good analytical skills and attention to detail
Effective time management in order to meet team objectives