Merz Therapeutics

Senior Clinical IT, Data Oversight Manager

Merz Therapeutics

full-time

Posted on:

Location Type: Office

Location: Frankfurt am Main • 🇩🇪 Germany

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Job Level

Senior

Tech Stack

Google Cloud PlatformPythonSQL

About the role

  • Join our motivated team as Senior Clinical IT & Data Oversight Manager (m/f/d) and play a key role in ensuring integrity, quality and compliance of clinical IT systems and trial data.
  • Oversee vendor systems, support data workflows, and contribute to the digital excellence of our clinical development activities.
  • Track and oversee clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); supporting audits, risk assessments and system evaluations.
  • Coordinate system updates and change management activities with service providers, including decommissioning and issue management.
  • Support qualification and validation of data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management.
  • Contribute to sponsor data quality oversight through critical data review, trend analysis and the use of data analytics and visualization tools (e.g., SAS, SQL, Python, Power BI).
  • Support documentation processes including identification, transfer, and archiving of essential system- and data-related documents.
  • Drive cross-functional collaboration with Clinical Development, Product Safety, QA and external partners, including training on compliance expectations.
  • Participate in audits and budget planning for clinical IT systems and contribute to the evaluation and implementation of new digital tools.

Requirements

  • Academic degree, preferable in data science or IT/computer science
  • 3 years of experience in setup and/or qualification of IT systems in a GCP-regulated environment
  • At least 3–4 years of 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 knowledge (e.g., SAS, SQL, Python) and hands-on experience
  • Strong communication skills, well-organized, reliable, proactive and collaborative mindset
  • Interest in IT topics and clinical development, and motivation to own and develop procedures and tools for effective sponsor oversight
Benefits
  • Individual career development with the purpose of improving the quality
  • Hybrid work model that allows a good work-life balance
  • Attractive location with good transport links, modern workplaces and company restaurants
  • International family business with flat hierarchies and an open, appreciative corporate culture
  • Attractive remuneration with extensive social benefits
  • Variety of employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits and JobBike

Applicant Tracking System Keywords

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

Hard skills
data managementdata analyticsdata visualizationprogrammingSASSQLPythonGCP complianceclinical trial systemschange management
Soft skills
communicationorganizationreliabilityproactivitycollaborationcritical thinkingtrend analysisproblem-solvingtrainingoversight