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EDC Developer
Eingestellt von Yoh
Gesuchte Skills: Design, Oracle, Client
Projektbeschreibung
JOB RESPONSIBILITIES:
- Provide eCRF and pCRF design analysis and recommendations to ensure best practices are instituted.
- Support the development and maintenance of EDC related SOPs and work instructions.
- Apply expertise in the software tools BHC is using to create eCRFs and collaborate on training for end-users with software vendors and CROs counterparts.
- Develop and Implement eCRF design and edit specifications including derivations for all assigned studies.
- Ensure they are complete and comprehensive and include custom functions prior to building the eCRF.
- Ensure that all eCRF testing is completed and documented, and provide input if eCRFs are audited.
- Archive eCRFs and pCRFs as defined by SOPs.
JOB QUALIFICATIONS:
- Medidata Rave Certification is required.
- Bachelor's degree or higher level degree in a biological science, Statistics, Computer Science, Engineering, or a scientific/quantitative/computer-oriented field and at least three to six (3-6) years related experience of which three (3) years is in clinical data management and/or data analysis of which two (2) years includes direct experience with Electronic Data Capture (EDC) design and deployment or a Bachelor's degree in any field with six to eight (6-8) years related data management experience of which four (4) years is in clinical data management and/or data analysis of which two (2) years includes direct experience with eCRF and database design and deployment.
- Experience with other clinical data management software (Oracle Clinical, Inform, SAS, etc.) including other eCRF development software (eg, Inform, etc.) is desirable.
- Experience with and knowledge of the clinical trial data management
- Process is required.
- Knowledge of basic medical terminology and physiological concepts is required.
- Knowledge of device or pharmaceutical industry regulatory requirements, and knowledge of
- device/pharmaceutical industry trends including the usage of CDISC
- Standards are desired.
DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.
Yoh, a DayJ2W: INFOTECH
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Tarrytown, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design