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Senior Clinical Database ProgrammerJob ID R0000001222 South, Illinois, United States of America
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is looking for a Senior Database Programmer to join their North America team!
The Senior Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. In addition, the Senior Database Programmer can assist the Database Primary or Technical Lead role on projects, and liaise with sponsors, Data Management Lead and other functional areas as required. General areas of responsibility also includes: eCRF design, edit check programming and integration of third-party systems with the EDC databases. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems
- Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based
- (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
- Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
- Accountable for first time quality on all deliverables.
- Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines.
- Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to by:
- Actively assume activities on a project as required.
- Monitor project resourcing and identify changes in scope.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
- Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues.
- Provide technical support and advice to the internal team.
- Ability to lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously.
- Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).
Support Projects & Technologies
- Assist in providing technical solutions to internal or external/client enquires.
- Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems)
- Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
- Maintain technical documentation that is applicable to the Clinical Database.
- Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
- Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies
Act as a mentor and/or SME
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work.
- Assist in providing technical solutions to internal or external client enquires.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
Support Business Development
- Support Bid defense meetings
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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