Contractor

HCL Technologies Ltd. Bristol County , MA 02790

Posted 2 weeks ago

Job Description (Posting).

Provide general IT support to business SME s for clinical systems

Understand clinical/biopharmaceutical operational data within systems/database schemas, be capable of deciphering technical information in specifications/reports and create the same in other systems/software, grasp system configurations to take part in problem-solving interface or system issues.

Collaborate with Business SME in investigating and trouble-shooting problems/errors occurring in CTMS interfaces/integrations and data quality issues within the Operational Data Repository

Resolve errors or incorporate feedback in GxP documentation, after quality and system SME reviews.

Responsible for CTMS data analysis, reviewing data queries, solving, and making recommendations to resolve data related issues.

Understand business processes, interconnected systems, and the type of data each system has, the inbound/outbound interfaces, to support the creation/update of architecture, configuration, data migration diagrams using Visio or relevant tools.

Develop Computer Systems Validation (CSV) deliverables including report specifications, technical/design specifications.

Develops GxP systems development lifecycle documentation on projects including clinical operational data repositories, master data management systems, and other clinical systems within the Global Clinical Operations (GCO) per applicable Standard Operating Procedures (SOPs) and regulatory requirements (Good Clinical Practices (GCP), Good Documentation Practices (GDP), Title 21 of the Code of Federal Regulations (21CFR))

Make use of relevant technologies to analyze clinical operations data to build descriptive reports/dashboards for various business teams (Sportfire, Power BI)

Provide technical support of multiple integrations, APIs, data warehouse maintenance etc. using PL/SQL, for query development, data analysis, troubleshooting, database schemas, view creation and joins as required.

Creating and documenting standards for reporting and business terminologies.

Maintain a database of data element definitions and ways of retrieving it, by comprehending clinical operational data per business process, to ensure consistency in usage and reported data, thereby preventing misinterpretation.

Can work independently on troubleshooting, looks for areas and suggests ideas for process improvement and technical solutions.

An Independent learner, adept and versatile with product support efforts. (1.) To create work plans, monitor and track the work schedule for on time delivery as per the defined quality standards. (2.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity. (3.) To ensure process improvement and compliance in the assigned module, and participate in technical discussionsorreview. (4.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.


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Contractor

HCL Technologies Ltd.