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Position Summary:

We are seeking a Technical Data Manager consultant to join our Data Management group. This person will serve as programmer to support clinical data systems and activities for multiple studies.

Key Responsibilities:

• Support internal team with programming requests in TIBCO Spotfire
• Work with Lead Data Manager to create and review the Data Transfer Agreement (DTA) or Data Transfer Specification (DTS); may work with IT to set up SFTP folder structure and ensure access is granted as per the DTA or DTS.
• Perform quality review of data transfers, ensuring the external data is of high quality and follows the structure and format of the DTA/DTS Ensure successful execution of clinical trials.
• Support EDC database build and migrations (i.e edit check specification development and/or review, user acceptance testing).
• Interact with Data Manager and other cross-functional colleagues, including Trial Manager/Clinical Operations Manager, Statistical Programmer and Biostatistician on data issue solution.
• Interact with Data Manager and external service providers, including lab vendors, technology vendors, DM vendor and CROs.
• Review the DMP and Data Flow Map to ensure all DTA/DTS are in place and up to date.
• Review programming specifications from technology vendors to ensure the DM technology vendors, SDTM vendors and statistical programmer is clear on which data from the EDC and the external data transfers are to be used for SDTM and analysis of the clinical trial.

Required Qualifications:

• BS or MS in Statistics, Computer Science, or other Analytical fields
• 4+ years of experience in Clinical Data Management programming or Clinical Data Systems engineering within the pharmaceutical industry
• Strong understanding of clinical trial processes, EDC build and DM Systems programming requirements for regulatory submissions
• Proficiency in utilizing and programming TIBCO Spotfire Data Visualization and Analytics
• Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development
• Understanding of CDISC compliant SDTM data and specifications
• Oncology experience is preferred

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