Senior Clinical IT & Data Oversight Manager (m/f/d)

🕒 vor 2 Monaten

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Merz Therapeutics

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2020

💊 Pharmazie

🧬 Biotechnologie

Pharmaceuticals • Biotechnology

Merz Therapeutics ist ein globales Spezialtherapieunternehmen, das sich auf die Entwicklung und Vermarktung von Medikamenten für neurologische, Bewegungs- und chronische Erkrankungen sowie Hepatologie und Dermatologie konzentriert. Das Unternehmen führt klinische Entwicklungsprogramme durch (einschließlich Phase-III-Studien), unterhält eine Produktpipeline, arbeitet mit Partnern und Forschern zusammen und legt großen Wert auf patientenzentrierte Dienstleistungen und Nachhaltigkeit in seinen internationalen Aktivitäten.

Beschreibung

• Join our motivated team as Senior Clinical IT & Data Oversight Manager and play a key role in ensuring 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 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.

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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