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

Merz Therapeutics; Frankfurt; Hybrid; EUR 75.000 - 90.000; Vollzeit

Zusammenfassung

A leading healthcare company based in Frankfurt is seeking a Senior Clinical IT & Data Oversight Manager. This role involves ensuring the integrity and compliance of clinical IT systems and trial data. Candidates should have a degree in data science or IT/computer science and at least 3 years of experience in a GCP-regulated environment. The successful applicant will play a key role in data oversight, vendor management, and cross-functional collaboration to enhance clinical development activities. A hybrid work model and attractive benefits are offered.

Leistungen

Hybrid work model

Individual career development

JobBike

Corporate Benefits

Qualifikationen

• 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.
• Fluent English (written and spoken), strong communication skills, organized and proactive.

Aufgaben

• Track and oversee clinical IT systems, ensuring compliance with regulations.
• Coordinate system updates and change management with service providers.
• Support data workflows and collaborate with other departments.

Kenntnisse

Data science

IT/computer science

GCP compliance

SAS

SQL

Python

Clinical Data Management

Communication skills

Collaboration

Ausbildung

Academic degree in data science or IT/computer science

Tools

EDC

IRT

eCRF

eCOA

CTMS

eTMF

Power BI

Jobbeschreibung

YOUR CONTRIBUTION

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. In this position, you will oversee vendor systems, support data workflows, and contribute to the digital excellence of our clinical development activities.

Your responsibilities will include the following:

• Tracking and overseeing clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); supporting audits, risk assessments and system evaluations
• Coordinating system updates and change management activities with service providers, including decommissioning and issue management
• Supporting qualification and validation of data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management
• Contributing 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)
• Supporting documentation processes including identification, transfer, and archiving of essential system- and data-related documents
• Driving cross-functional collaboration with Clinical Development, Product Safety, QA and external partners, including 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

YOUR PROFILE

• 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

YOUR 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