Minimum 4-5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred.
Strong experience in preparations for NDA filings
Solid knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
Knowledge of CDISC related data models like SDTM, and ADAM.
Experience of working on multiple clinical protocols at the same time.
Excellent verbal and written communication skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
Excellent team player