Merz Therapeutics

Senior Clinical IT & Data Oversight Manager

Merz Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Frankfurt am Main • Germany

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Job Level

Senior

Tech Stack

Google Cloud PlatformPythonSQLTypeScript

About the role

  • Tracking and monitoring of clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); supporting audits, risk analyses and system assessments
  • Coordination of system updates and change management activities with vendors/service providers, including decommissioning and issue management
  • Support of qualification and validation processes for data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management
  • Contributing to sponsor data quality monitoring through targeted data reviews, trend analyses, and use of data analysis and visualization tools (e.g., SAS, SQL, Python, Power BI)
  • Supporting documentation processes, including identification, transfer and archiving of essential system- and data-specific documents
  • Promoting cross-functional collaboration with Clinical Development, Product Safety, QA and external partners, including providing training on compliance expectations
  • Participating in audits and budget planning for clinical IT systems and contributing to the evaluation and implementation of new digital tools

Requirements

  • Academic degree, preferably in Data Science or IT/Computer Science
  • 3 years' experience in setting up and/or qualifying IT systems in a GCP-regulated environment
  • At least 3–4 years' experience in Clinical Data Management
  • Understanding of GCP requirements for IT systems; experience with clinical trial systems (e.g., EDC, IRT, eCRF, eCOA, CTMS, eTMF)
  • Fluent English (written and spoken)
  • Strong understanding of IT and data processes
  • Programming skills (e.g., SAS, SQL, Python) and hands-on experience
  • Strong communication skills; well organized, reliable, with a proactive and collaborative mindset
  • Interest in IT topics and clinical development, and motivation to adopt and further develop procedures and tools for effective sponsor oversight
Benefits
  • Individual career development focused on improving quality
  • Hybrid working model enabling a good work–life balance
  • Attractive location with good transport links, modern workspaces and company cafeterias
  • International family-owned company with flat hierarchies and an open, appreciative corporate culture
  • Competitive compensation with comprehensive social benefits
  • A range of employer-sponsored benefits such as WellPass, Deutschlandticket (public transport pass), Corporate Benefits and JobBike
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASSQLPythondata analysisdata visualizationqualification processesvalidation processeschange managementrisk analysistrend analysis
Soft Skills
strong communication skillswell organizedreliableproactive mindsetcollaborative mindset