Senior Database Developer

Functional Services United States


Description

Position at Premier Research Group Limited

Company Name:                    Premier Research International, LLC

Position Title:                           Senior Database Developer

Location:                                 One Park Drive, Ste 150, Durham, NC 27709

                                                                               

Summary of Duties:              

Serves as a member of the project team with primary responsibility for developing project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms.

 

RESPONSIBILITIES:

  • Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies.
  • Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies.
  • Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met.
  • Designs, builds and tests clinical databases according to Premier Research standard operating procedures and/or client standard operating procedures.
  • Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
  • Writes data extraction programs.
  • Development of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
  • Produces database documentation including an annotated CRF.
  • Ensures database documentation is maintained for the Trial Master File.
  • Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan
  • Performs system testing and Quality Control (QC) of specified deliverables
  • May assist in maintaining the Clinical Data Management Systems global and program libraries
  • May be required to undertake additional programming tasks as needed
  • May be required to participate in a flexible coverage schedule based on business need
  • All other projects as assigned.
  • Can work remotely.

 

Qualifications:                        

Bachelor’s degree in Computer Science, Engineering, Clinical Research, Healthcare or related AND 5 years of experience in clinical database development. (Employer will accept 1 year of related experience in lieu of 1 year of education).

 

Applicants must have 5 years of experience with:

 

  • Clinical trials support or pharmaceutical industry with practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC/Inform, Medidata Rave, or DataLabs)
  • Using computerized information systems including commercial clinical data management systems and Microsoft Office Suite of tools (eg - Outlook, Word, and Excel)
  • Database development processes, SOPs, and working guidelines
  • FDA Guidance Documents, EU Directives, ISO14155 regulations, and drug/device development

 

Demonstrated experience with the following:

 

  • ICH and local regulatory authority drug research and development regulations
  • Web based communication tools for conferences such as Webex or Microsoft Lync