Are you aN Implementation Consultant looking to work for a multiple award-winning global biometric Contract Research Organization? My client partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services.

KEY RESPONSIBILITIES:

• Participate in study specific eCRF programming strategy meeting at study set up

  Perform senior review of eCRF specifications created by the study teams

• Build clinical study database CRF database screens per CRF/database specifications provided by the study team.
• Complete study database updates as specified per database modification documents and procedures
• Perform senior review of Data Review Convention specifications created by the study teams

  Create/Program edit checks, special action and derivations as per the Data Review Convention specifications

• Ensure non-eCRF technologies for data capture (e.g., ePRO, coding, IWRS/RTSM) are deployed as per requirements, including integrations with other systems, platforms or reporting environments.
• Provide expert advice for Data Operations project innovation - report progress, risks and issues to senior management.
• Lead the implementation, accreditation and validation tasks for new software required to conduct Data Operations tasks.

SKILLS AND EXPERIENCE REQUIRED:

• Certified Medidata Rave builder in EDC and Coder.
• Proven ability to design Screens & program Edits and Custom Functions in Medidata RAVE EDC.
• Design and program Custom Functions in Medidata RAVE EDC (Ideally accredited in Custom Function and use of C#).
• CDASH and SDTM standards
• University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution

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