Clinical Data Standards Consultant ICON Strategic Solutions

2.0 - 6.0 years

0 Lacs

karnataka

On-site

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Princ...

Posted 4 months ago

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Senior CDA, Senior Statistical Programmer A global CRO.

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior S...

Posted 4 months ago

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Analyst II External Data Acquisition Expert Amgen Technology Private Limited

5.0 - 10.0 years

5 - 10 Lacs

Mumbai, Maharashtra, India

On-site

We're looking for an experienced professional to join our team in Hyderabad, accountable for the setup and maintenance of External Data Streams within assigned clinical trials. You'll ensure these streams adhere to best practices and defined guidelines, contributing to the integrity and efficiency of our clinical data. Key Responsibilities Accountable for the setup and maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines. External Data Streams include, but are not limited to, ePRO, eSource, EHR, Real World data , and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS). Your activities and deli...

Posted 5 months ago

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