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Openings for Clinical Database Programmer At PAREXEL
Posted October 10, 2011
· 2 - 4 Years
Organization
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Role
Designation Clinical Database Programmer II (OC / OCRDC)
Job Description
Essential Function
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.
Coordinate and execute system specific project start-up activities.
Configure & implement eClinical applications/systems specifically required in a project including but not limited to Medical
Safety Reporting (ISIS), ARGUS, CTMS (IMPACT), PMED.
Execute ongoing maintenance tasks, performance evaluations and tuning of eClinical applications/systems
Provide optimum monitoring, support, and maintenance of a reliable, quality, integrated eClinical application/system
environment.
Set up / configure automatic reports for studies within the eClinical applications/systems.
Execute automatic import and export of data.
Desired Profile
Skills
Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
Knowledge of the programming and reporting process within GTS.
Knowledge of WSOPs/Guidelines/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 in a relevant discipline is preferred or equivalent work experience.
Language Skills
Excellent written and oral communication skills.
Minimum Work Experience
Relevant Clinical Trial industry experience
Experience working with systems used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS,
Medical Safety Reporting)
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Software Developer
Functional Area Application Programming, Maintenance
Education UG - B.Sc - Computers,B.Tech/B.E. - Computers,BCA - Computers
PG - M.Sc - Computers,M.Tech - Computers,MCA - Computers
Location Hyderabad / Secunderabad
Keywords SAS, SDTM Mapping, UAT Testing, Oracle Clinical, Inform, RAVE
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com
Job Description
Essential Function
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.
Coordinate and execute system specific project start-up activities.
Configure & implement eClinical applications/systems specifically required in a project including but not limited to Medical
Safety Reporting (ISIS), ARGUS, CTMS (IMPACT), PMED.
Execute ongoing maintenance tasks, performance evaluations and tuning of eClinical applications/systems
Provide optimum monitoring, support, and maintenance of a reliable, quality, integrated eClinical application/system
environment.
Set up / configure automatic reports for studies within the eClinical applications/systems.
Execute automatic import and export of data.
Desired Profile
Skills
Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
Knowledge of the programming and reporting process within GTS.
Knowledge of WSOPs/Guidelines/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 in a relevant discipline is preferred or equivalent work experience.
Language Skills
Excellent written and oral communication skills.
Minimum Work Experience
Relevant Clinical Trial industry experience
Experience working with systems used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS,
Medical Safety Reporting)
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Software Developer
Functional Area Application Programming, Maintenance
Education UG - B.Sc - Computers,B.Tech/B.E. - Computers,BCA - Computers
PG - M.Sc - Computers,M.Tech - Computers,MCA - Computers
Location Hyderabad / Secunderabad
Keywords SAS, SDTM Mapping, UAT Testing, Oracle Clinical, Inform, RAVE
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com