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Clinical Data Management Specialist

hace 2 meses


Caimito Barrio, Puerto Rico Katalyst Healthcares And Life Sciences A tiempo completo

Job Summary

At Katalyst Healthcares And Life Sciences, we are seeking a skilled Clinical Data Management Specialist to join our team. The successful candidate will be responsible for managing assigned projects and ensuring deliverables are on-time. This includes owning all data management aspects for assigned projects from start-up to completion, including database modifications post go-live. The ideal candidate will have experience in database programming and eCRF configuration, as well as knowledge of clinical data standards such as CDISC CDASH/SDTM. Additionally, they will be familiar with GCP, ICH, and GCDMP, and have a strong understanding of FDA 21 CFR Part 11, HIPAA, GDPR, and Annex 11. The successful candidate will also be comfortable working in a customer-facing role and communicating regularly with customers.

Key Responsibilities

• Develop data management plans and guidelines to ensure high-quality clinical data
• Design and configure electronic case report forms (eCRFs) and all associated documentation, including completion guidelines and instructions
• Execute all data management activities in compliance with internal SOPs, industry regulations, and GCP standards
• Work cross-functionally between departments to answer customer questions, including RFIs and RFPs
• Identify opportunities for expanding professional services to enhance customer satisfaction and drive business growth

Requirements

• Experience in database programming and eCRF configuration
• Knowledge of clinical data standards such as CDISC CDASH/SDTM
• Familiarity with GCP, ICH, and GCDMP
• Strong understanding of FDA 21 CFR Part 11, HIPAA, GDPR, and Annex 11
• Comfortable working in a customer-facing role and communicating regularly with customers