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Sr. Clinical Programmer (EDC Specialist)

Compass Consulting Group, San Francisco CA


Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. 

 

Duties:
  • The position is an integral part of Clinical Data Management (CDM) responsible for the development, implementation and maintenance of the systems and applications supporting Drug Development across multiple therapeutic areas. 
  • This position will function as the subject matter expert for EDC, data acquisition, archive and interchange of data for clinical research studies and the clinical reporting environment.
  • They will support the development of EDC standards for data collection and data transmission; and collaborate with cross-functional teams to develop new therapeutic area standards and supporting data review tools. 
  • The Clinical Programmer will define best practices for data acquisition and develop Nektar standards adhering to CDISC conventions and regulatory guidelines. 
  • This position will develop and maintain a global library of standard forms, edit checks, reports and data listings used to facilitate the clinical development process.
  • This position contributes to and supports the company' s research and development efforts to create high value therapeutics to address unmet medical needs.

 

Skills:
  • Works on extremely complex problems in which analysis of situations for data requires an evaluation of intangible variables.
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Provide leadership and direct activities in the areas of Database Design/Programming, Systems Development/Support and Training.
  • Function as EDC and CDISC expert providing guidance and best practices to clinical teams.
  • Advise and direct the teams about standards in CRF development, validation, and reporting.
  • Implement and maintain standards for data collection, acquisition, archival, and submission of data for clinical research studies in accordance with appropriate regulatory guidance (CDISC).
  • Oversee EDC development and testing environments.
  • Perform functional auditing and vendor qualifications.  
  • Develop and maintain Nektar global standards and project specific specifications.
  • Define programming and reporting standards, conventions and rules.
  • Define regulatory-compliant data exchange standards with both external business partners (CRO, central labs, IXRS, eCOA, etc.) and internal partners (Biostatistics, Clinical Operations, etc.).
  • Oversee activities related to external vendors supporting multiple trials to ensure consistency in data collection, transmittal and reporting. Implement and maintain a regulatory-compliant process for acquisition, archive, and interchange of clinical study data.
  • Co-ordinate with CRO’ s on data collection instruments, reporting tools, and system requirements. Implement a tracking mechanism for process and clinical system-related issues.

 
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