Senior Clinical IT & Data Oversight Manager

🕒 March 16

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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

• Join our motivated team as Senior Clinical IT & Data Oversight Manager and play a key role in ensuring the integrity, quality and compliance of clinical IT systems and trial data. • Track and oversee clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); support 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 in collaboration 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 providing 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

• University degree, preferably in Data Science or IT/Computer Science • Minimum 3 years' experience in the setup and/or qualification of IT systems within a GCP-regulated environment • At least 3–4 years' experience in Clinical Data Management • Solid understanding of GCP requirements for IT systems; experience with clinical trial systems (e.g., EDC, IRT, eCRF, eCOA, CTMS, eTMF) • Fluent in English (written and spoken) • Strong understanding of IT and data processes • Programming knowledge (e.g., SAS, SQL, Python) with hands-on experience • Excellent communication skills; well organized, reliable, proactive and collaborative • Interest in IT topics and clinical development, with the motivation to own and improve procedures and tools for effective sponsor oversight

🏖️ Benefits

• Individual career development with a focus on improving quality • Hybrid work model that supports a healthy 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 • Variety of employer-subsidized benefits such as WellPass, Deutschlandticket (Germany public transport ticket), Corporate Benefits and JobBike