Ref #: 37058
Employment type: Permanent - Full-Time
Location: Bangalore/Chennai/Homebased
Posted: 06-May-2022
Description
Job Purpose:
The Clinical Programmer is primarily responsible for LSH Setup and Data Loading activities (both Inbound and Outbound) with External Data providers. Also provide support to manage the load, Transfer and conform Clinical Trial Data to Internal standards and the provision of Clinical Data extracts to Clinical Data Consumers of study-level or project level deliverables under minimal guidance.
Major Activities:
1. Contibute to LSH and Data Loading activities as Associate Clinical Programmer for phase I to IV clinical studies in Global Drug Development.
2. Participate in the review of Data Transfer specification documents and provide comments if required. Also perform Data Loading activities so that data flow is available once the third party data is obtained from external vendors. Address QC findings prior to Production Loads.
3. Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models).
4. Responsible for Study Conduct activities that includes Conformance of Clinical data to internal data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders.
5. As part of the Setup activities, responsible for the maintenance and daily operational support that includes Data processing activities during Study conduct like reviewing Job Logs, address Error/Failure notifications, blinding process of Third Party Data.
6. Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third Party Vendors.
7. Need to have good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables.
8. Participate in all Subject matter expert (SME) activities and help on any functional testing activities.
9. Build and maintain effective working relationship with cross-functional team.
10. Comply and adhere to SOPs with standards and processes to support the LSH Setup and Data Loading Activities.
11. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications.
12. Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups.
13. Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
14. Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.
Experience/Professional requirement:
1. Ideally 2-5 years of work experience in a programming role preferably supporting multiple clinical trials across various theraupautic areas.
2. Good understanding of Mapping, ETL or Data Warehousing activities.
3. Good understanding of Metadata Standards Management like CDISC SDTM, LSH.
4. Goodknowledge of Global Clinical Trial Practices, procedures and Data presentation.
5. Good understanding of related applications that are Data collection tools (like OC, Rave) and ancillary data.
6. Good understanding of Regulatory requirements.
7. Good communications and negotiation skills, ability to work well with others globally.
Education (minimum/desirable):BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
The Clinical Programmer is primarily responsible for LSH Setup and Data Loading activities (both Inbound and Outbound) with External Data providers. Also provide support to manage the load, Transfer and conform Clinical Trial Data to Internal standards and the provision of Clinical Data extracts to Clinical Data Consumers of study-level or project level deliverables under minimal guidance.
Major Activities:
1. Contibute to LSH and Data Loading activities as Associate Clinical Programmer for phase I to IV clinical studies in Global Drug Development.
2. Participate in the review of Data Transfer specification documents and provide comments if required. Also perform Data Loading activities so that data flow is available once the third party data is obtained from external vendors. Address QC findings prior to Production Loads.
3. Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models).
4. Responsible for Study Conduct activities that includes Conformance of Clinical data to internal data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders.
5. As part of the Setup activities, responsible for the maintenance and daily operational support that includes Data processing activities during Study conduct like reviewing Job Logs, address Error/Failure notifications, blinding process of Third Party Data.
6. Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third Party Vendors.
7. Need to have good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables.
8. Participate in all Subject matter expert (SME) activities and help on any functional testing activities.
9. Build and maintain effective working relationship with cross-functional team.
10. Comply and adhere to SOPs with standards and processes to support the LSH Setup and Data Loading Activities.
11. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications.
12. Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups.
13. Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
14. Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.
Experience/Professional requirement:
1. Ideally 2-5 years of work experience in a programming role preferably supporting multiple clinical trials across various theraupautic areas.
2. Good understanding of Mapping, ETL or Data Warehousing activities.
3. Good understanding of Metadata Standards Management like CDISC SDTM, LSH.
4. Goodknowledge of Global Clinical Trial Practices, procedures and Data presentation.
5. Good understanding of related applications that are Data collection tools (like OC, Rave) and ancillary data.
6. Good understanding of Regulatory requirements.
7. Good communications and negotiation skills, ability to work well with others globally.
Education (minimum/desirable):BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field