Senior Clinical IT & Data Oversight Manager

🕒 February 15

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Merz Therapeutics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Merz Therapeutics is a global specialty therapeutics company focused on developing and commercializing medicines for neurological, movement and chronic conditions as well as hepatology and dermatology. The company runs clinical development programs (including Phase III trials), maintains a product pipeline, works with partners and investigators, and emphasizes patient-centric services and sustainability across its international operations.

📋 Description

• 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