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Career Opportunity in Parexel | Join as Quality Specialist, Clinical Data Analyst I (Coder), Clinical Database Programmer II, Quality Specialist II


Post: Clinical Database Programmer II

Job Description:
The Clinical Database Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems and/or the applications/systems within eClinical technologies. There are two specific functions that
may be filled by the Clinical Database Programmer II, dependent on skill sets and experience; Clinical Systems and Support Programmer and Database Programmer.

Key Accountabilities
- Deliver best value and high quality service.
- Ensure quality control (QC) on all process and technical activities related to:
- trial set-up and maintenance, and/or
- implementation of system applications and upgrades/changes
to those applications as required
- are performed in accordance with corporate quality
standards, SOPs / Guidelines / Work Instructions , ICH-GCP
and/or other local or international regulatory requirements.
- Check own work in an ongoing way to ensure first-time quality.
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work
Instructions to ensure traceability and regulatory compliance.
- Proactively participate in quality improvement initiatives.
- Ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCP and any other applicable local or international regulations and participate in internal/external audits and regulatory
inspections as required.
- Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical areas.
- 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.

Database Programmer
- 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.
- 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.
- Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
- Perform small to medium size ad-hoc programming tasks.

Experience:
- Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
- Knowledge of the programming and reporting process within GRO.
- Knowledge of SOPs/Guidelines/WorkInstructions/ System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven
practical application.
- Demonstrate ability to learn new systems and function in an evolving technical environment.
- Attention to detail.
- Ability to work together with a team (including international teams as required) as well as independently.
- Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
- Business/Operational skills that include customer focus, commitment to quality management and problem solving.
- Work effectively in a quality-focused environment.

Education
Graduate or equivalent in a relevant discipline is preferred or equivalent work experience.

Language Skills
- Very good English written and oral communication skills.

Minimum Work Experience
- 3 to 4 years of SAS/RAVE experience in ecrf build, editchecks build, Transfer programming, offline listings and other SAS related tasks. SDTM experience is must
- Experience working with at least one system used within the Clinical Trial process(e.g., SAS,CDMS, EDC (Inform,RAVE,DataLabs), CTMS, Medical Safety Reporting)

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Data management
End Date: 20th Jan, 2012

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