Clinical Data Management Systems Lead

hace 1 día


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

Msd seeks an experienced Clinical Data Management Systems Lead to join our team.

About the Role

As a Clinical Data Management Systems Lead, you will be responsible for creating and developing clinical databases and data transfer files according to written specifications. You will lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in the transfer of electronic data files into the Clinical Data Management System (CDMS).

You will interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables. Your responsibilities will include data mapping deliverables, such as SDTM structure set-up and transformation maps to support multiple clinical programs.

Key Responsibilities
  • Create and develop mapping specifications to meet SDTM structure requirements utilizing E2E visibility tools to ensure quality and timeliness of data flow.
  • Lead and participate in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.
  • Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.
  • Coordinate data reporting activities for multiple clinical programs.
  • Create and review reporting specifications to ensure high-quality deliverables, meet SDTM structure requirements, and the needs of the business.

You will lead and participate in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database. Additionally, you will assume responsibility for all database Archiving and Decommissioning activities in support of multiple clinical programs.

Requirements
  • B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.
  • Knowledge of database structures and available tools to manage, extract, report, and warehouse data.
  • Minimum 4 years of database development or data programming experience, at least three of which including clinical databases.
  • Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer, SQL-PL/SQL).
  • Minimum 4 years of experience with CDISC Standards, (SDTM, CDASH, Define.xml).
  • XML, Java.
  • ELT tools.
  • 3+ years' experience in data transformations and data loading in tools such as InForm.
  • 2+ years' experience in System Development Lifecycle Management / system validation knowledge.
  • 3+ years' experience with reporting tools such as Cognos or JReview.
  • Experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.
  • Advanced knowledge of the Data Management process from study start-up through close-out.
  • Ability to collaborate and communicate with cross-functional stakeholders to interpret and ensure quality report specifications and input to report development.
  • Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.
  • Strong organizational and critical thinking skills.
  • Keen sense of urgency and customer focus.
  • Ability to work cross-functionally and as part of a team.
  • Able to work independently, under pressure, and change environment with flexibility.
Estimated Salary Range

$120,000 - $180,000 per year, depending on experience.



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