Clinical Data Management Lead

hace 3 semanas


San José, San José, Costa Rica Msd A tiempo completo

Msd is seeking a Clinical Data Management Lead to join our team.

Job Description

The Clinical Data Management Lead will be responsible for leading and participating in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).

The ideal candidate will have a minimum of 4 years of experience with CDISC Standards, XML, Java, ELT tools, InForm, Inform Architect, Central Designer, SQL-PL/SQL, and reporting tools such as Cognos or JReview.

Key Responsibilities:

  • Liaise with study teams and key stakeholders to integrate requirements into all deliverables
  • Ensure adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines
  • Develop required training and provide ongoing training and development to Developers on standards and Study Build, transformations, mapping, reporting, and Archival Process
  • Interface with functional manager to assure consistency of technical and process strategies across all therapy areas

Requirements:

  • B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science
  • Minimum 4 years of database development or data programming experience, at least three of which including clinical databases

Salary: $110,000 - $140,000 per annum

Benefits

Msd offers a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Others

This role requires a strong understanding of the drug discovery process, FDA regulations, and GxP guidelines. The ideal candidate will be able to work independently, under pressure, and change environment with flexibility.



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