Clinical Database Programmer I
2 months ago
India, Remote
**Additional Locations**: Hyderabad, Telangana, India
**Job ID** R0000028188
**Category** Data Management
**ABOUT THIS ROLE**:
**Job Purpose**
**Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems**
- 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.
- 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
**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 level agreements with regard to the turnaround time from the point when specifications are finalized
**Documentation**
- 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.
**Skills**:
- Ability to collaborate with global teams and work independently
- Good interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
- Demonstrate ability to learn new systems and function in an evolving technical environment.
- A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
- Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
- Commitment to first time quality, including a methodical and accurate approach to work activities
- Time management and prioritization skills in order to meet objectives and timelines
- Evidence of strong problem-solving skills including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
- Ownership and accountability relative to Key Accountabilities in Job Description
- Written and oral fluency in English
**Knowledge and Experience**:
- Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
- Experience in clinical research industry or similar field is desired
**Education**:
- Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.
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