Senior Database Developer
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.
- 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.
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