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Oppurtunity for Technical Analyst At PAREXEL
Posted November 2, 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 Technical Analyst
Job Description
Essential Function
Provide technical expertise and resource for the conduct of specification development, functional and technical testing,
General areas of responsibility include: specification creation, database development testing and development of
specifications for programming the data consistency checks, test data creation and testing program¿s; import/export
programming testing and specification development, as well as mapping specifications to support relevant data standards.
Perform responsibilities in accordance to corporate quality standards, SOPs/Guidelines, ICH-GCP and/or other international
regulatory requirements.
Key Accountabilities
General
Be a centralized Technical Analysts group for all supported technologies within Global Technical Services (GTS).
Independent group to perform both Functional and Technical testing of electronic as well as paper databases and Validation
Programming.
To have individuals who understand specific technologies and be crossed trained in other systems
Provide input into other Clinical Programming Group activities as required or reasonably requested.
Participate in the rollout of Process and Systems as part of the project implementation teams, when required.
Work closely with the Quality Process and Training (QPT) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other
applicable local and international regulations.
Deliver best value and high quality service for the benefit of the Clinical Data Analysts (CDA) through the application of
system implementation.
Ensure adherence to service levels agreements to a turnaround time from when specifications are finalized
Works closely with IT, QPT, and DM operations staff to ensure continuous process improvement.
Clinical Support
Design and review of Case Report Form (CRF), and incorporate any feedback and gain acceptance from the client. If appropriate
this will require NCR printing
Programming, DVS and export specifications based on final eCRF (CRF).
Creates test scripts and test data for all the CDMS and EDC technologies.
Provide review of eCRF¿s / Screens and enter test data into database.
To work closely with GRO to understand logic required to create tests and translate into the DVS for the Clinical Programmers
(CPs) to program.
Quality Check & Testing
Define & QC Codebook
QC Program test data generation.
To produce and design specification and test plan and scripts to support the functional and technical testing of systems
Set-up, test and approve existing relevant tools, to ensure that this has been documented in the standard QC checklist and
ensure process compliant to the use of the tool.
Participate in internal/external audits and regulatory inspections as required.
Perform quality control on all technical activities related to trial set-up and processing in accordance with corporate
quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements.
Training
Ensure that suitable training in client WSOP is accomplished.
Documentation Management
Create Database Documentation
Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure
that documentation is compliant with corporate quality standards, SOPs/Guidelines, appropriate regulations and Validation
requirements.
Coordinate the central filing of documentation in a secure central repository.
Maintain technical documentation - parts that are applicable to the Technical Analyst Group.
Maintain all supporting documentation in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
Document any deviations and disseminate to the rest of the group.
Programming & Systems & Data Standards
Implement standards (CDISC, HL7, PAREXEL, Client) for database specification
Implement mapping specifications related to (CDISC, HL7, PAREXEL, Client) for exports.
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.
Participate in the creation of standards, either through toolsets, libraries or processes, as required for GRO or GTS to
ensure efficient, effective and optimal process.
Assist in providing a technical solution back to the internal or external client.
Operational
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and
PAREXEL WSOP and stud specific procedure
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
Desired Profile
Skills
Business / Operational skills that include customer focus, commitment to quality management and problem solving.
Influencing skills including negotiation and teamwork.
Ability to manage multiple and varied tasks.
Attention to detail and strong organizational skills.
Ability to work independently and prioritize workload.
Good understanding of System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.
Experience in the maintaining and supporting of processes in a distributed client base within a regulated environment
Proficiency in a programming environment and understanding of relational databases.
Understanding of IT and the departments with GSM.
Good Analytical Skills, and attention to detail
Minimum Work Experience
2+ years of experience in mutiple EDC technology (Eg. Inform, RAVE and Central Designer).
Education
B.C.A. / M.C.A. / M.Sc. / B.S. / B.Sc. / B.A. in a science or industry related discipline
Language Skills
Good English written and oral communication skills
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Testing Engnr
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 UAT Testing, OCRDC, INFORM, RAVE, Oracle Clinical, SDTM Mapping
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com
Job Description
Essential Function
Provide technical expertise and resource for the conduct of specification development, functional and technical testing,
General areas of responsibility include: specification creation, database development testing and development of
specifications for programming the data consistency checks, test data creation and testing program¿s; import/export
programming testing and specification development, as well as mapping specifications to support relevant data standards.
Perform responsibilities in accordance to corporate quality standards, SOPs/Guidelines, ICH-GCP and/or other international
regulatory requirements.
Key Accountabilities
General
Be a centralized Technical Analysts group for all supported technologies within Global Technical Services (GTS).
Independent group to perform both Functional and Technical testing of electronic as well as paper databases and Validation
Programming.
To have individuals who understand specific technologies and be crossed trained in other systems
Provide input into other Clinical Programming Group activities as required or reasonably requested.
Participate in the rollout of Process and Systems as part of the project implementation teams, when required.
Work closely with the Quality Process and Training (QPT) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other
applicable local and international regulations.
Deliver best value and high quality service for the benefit of the Clinical Data Analysts (CDA) through the application of
system implementation.
Ensure adherence to service levels agreements to a turnaround time from when specifications are finalized
Works closely with IT, QPT, and DM operations staff to ensure continuous process improvement.
Clinical Support
Design and review of Case Report Form (CRF), and incorporate any feedback and gain acceptance from the client. If appropriate
this will require NCR printing
Programming, DVS and export specifications based on final eCRF (CRF).
Creates test scripts and test data for all the CDMS and EDC technologies.
Provide review of eCRF¿s / Screens and enter test data into database.
To work closely with GRO to understand logic required to create tests and translate into the DVS for the Clinical Programmers
(CPs) to program.
Quality Check & Testing
Define & QC Codebook
QC Program test data generation.
To produce and design specification and test plan and scripts to support the functional and technical testing of systems
Set-up, test and approve existing relevant tools, to ensure that this has been documented in the standard QC checklist and
ensure process compliant to the use of the tool.
Participate in internal/external audits and regulatory inspections as required.
Perform quality control on all technical activities related to trial set-up and processing in accordance with corporate
quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements.
Training
Ensure that suitable training in client WSOP is accomplished.
Documentation Management
Create Database Documentation
Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure
that documentation is compliant with corporate quality standards, SOPs/Guidelines, appropriate regulations and Validation
requirements.
Coordinate the central filing of documentation in a secure central repository.
Maintain technical documentation - parts that are applicable to the Technical Analyst Group.
Maintain all supporting documentation in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
Document any deviations and disseminate to the rest of the group.
Programming & Systems & Data Standards
Implement standards (CDISC, HL7, PAREXEL, Client) for database specification
Implement mapping specifications related to (CDISC, HL7, PAREXEL, Client) for exports.
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.
Participate in the creation of standards, either through toolsets, libraries or processes, as required for GRO or GTS to
ensure efficient, effective and optimal process.
Assist in providing a technical solution back to the internal or external client.
Operational
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and
PAREXEL WSOP and stud specific procedure
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
Desired Profile
Skills
Business / Operational skills that include customer focus, commitment to quality management and problem solving.
Influencing skills including negotiation and teamwork.
Ability to manage multiple and varied tasks.
Attention to detail and strong organizational skills.
Ability to work independently and prioritize workload.
Good understanding of System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.
Experience in the maintaining and supporting of processes in a distributed client base within a regulated environment
Proficiency in a programming environment and understanding of relational databases.
Understanding of IT and the departments with GSM.
Good Analytical Skills, and attention to detail
Minimum Work Experience
2+ years of experience in mutiple EDC technology (Eg. Inform, RAVE and Central Designer).
Education
B.C.A. / M.C.A. / M.Sc. / B.S. / B.Sc. / B.A. in a science or industry related discipline
Language Skills
Good English written and oral communication skills
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Testing Engnr
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 UAT Testing, OCRDC, INFORM, RAVE, Oracle Clinical, SDTM Mapping
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com