The employer requires a Bachelors degree in Engineering, HealthRelated Field, or closely related field.br br Employer also requires at least five 5 years of progressively more responsible work experience in any occupation managing global i.e., across more than one country teams involved with clinical data management activities in the pharma or biotech industry.br br Additionally, the employer requiresbr br 1. Demonstrated ability in advanced database programming skills including custom function development, custom scripts creation, custom datasets creation, global data standards creation, GCP validation and maintenance gained through at least five 5 years of work experience;br 2. Demonstrated ability working with Medidata RAVE EDC and RAVE Web Service gained through at least five 5 years of work experience;br 3. Demonstrated ability working with clinical systems including at least 3 of the following CTMS, IRT, Rave Safety Gateway, and ePro gained through at least three 3 years of work experience;br 4. Demonstrated understanding of clinical trial development in oncology therapeutic area gained through at least five 5 years of work experience; andbr 5. Demonstrated knowledge of FDAEMANMPA Regulations, ICH GCP Guidelines, CDISC Data Standards CDASH, SDTM, and Clinical Database Development Lifecycle Management gained through at least five 5 years of work experience.br br All years of experience may be gained concurrently.br br Travel required approximately 46 times per year 80 of which is domestic; 20 of which is international. Beneficiary is willing to meet travel requirement.
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