Senior Manager Clinical Operations (m/f/d)

Fresenius; Bad Homburg vor der Höhe; On-site; EUR 90,000 - 150,000; Full time

Job summary

Fresenius is seeking a Senior Manager Clinical Operations (m/f/d) to lead national and international clinical studies, align internal and external partners, and ensure quality, compliance, timelines and budget adherence.

You will plan and oversee study protocols, CROs, TMF, site selection, audits and CAPAs, manage cost planning and reporting, and support publication of results in coordination with the team; requires a university degree and 5+ years of GCP project or trial management with English

Qualifications

• Completed university degree in natural sciences or related field.
• At least five years of experience as a Project Manager or Clinical Trial Manager in the GCP area.
• Experience guiding and supporting colleagues.
• Proven ability to manage several projects simultaneously within budgets, timelines, and quality requirements.
• Interest in Real-World Evidence and AI applications in clinical research.
• Excellent written and verbal communication in English and German.

Responsibilities

• Plan, organize, conduct, oversee, and evaluate national and international single-center and multicenter clinical studies according to ICH-GCP and regulations.
• Oversee CROs and external service providers, including proposals and oversight.
• Prepare study protocols, case report forms, and final reports; manage study databases entry.
• Maintain Trial Master File and select study sites and DSMB members.
• Coordinate investigator and DSMB meetings; sponsor oversight and site co-monitoring.
• Manage investigational product supply and communicate with authorities and ethics committees.
• Prepare for audits/ inspections and implement CAPAs.
• Handle cost planning, budgeting, and monthly study status reporting.
• Contribute to SOP updates, regulatory documents, and dissemination of results.

Skills

Project Management

Clinical Operations

Leadership

Communication

German language

English language

Education

University degree (natural sciences or related)

Tools

Microsoft Office

Outlook

Job description

Shape the successful delivery of national and international clinical studies. As Senior Manager Clinical Operations (m/f/d), you will lead complex study projects, bring internal and external partners together, and ensure that studies meet defined quality, compliance, timeline, and budget requirements.

Your Responsibilities

• Plan, organize, conduct, oversee, and evaluate national and international single-center and multicenter clinical studies in accordance with ICH-GCP, applicable regulations, and internal SOPs
• Obtain and review proposals from CROs and select, guide, and oversee CROs and other external service providers
• Conceptualize and prepare study protocols, case report forms, and final reports, and ensure the required entries in internal and external study databases
• Continuously maintain study documentation, including the Trial Master File, and select study sites and DSMB members
• Organize and conduct investigator and DSMB meetings, perform sponsor oversight activities, and support co-monitoring and oversight of study sites
• Coordinate investigational product supply and document investigational product consumption, and provide information to authorities and ethics committees
• Prepare for and participate in audits and inspections, and prepare and continuously implement required corrective and preventive actions (CAPAs)
• Take responsibility for cost planning, budgeting, and monthly study status reporting in accordance with internal requirements
• Contribute to relevant SOP updates, regulatory documents, and the presentation or publication of study results, participate in relevant congresses in coordination with the supervisor, and provide subject-matter guidance and support to colleagues

Your Qualifications

• Completed university degree in natural sciences, preferably in biology, biochemistry, pharmaceutical sciences, nutrition or a related field
• At least five years of experience as a Project Manager or Clinical Trial Manager in the GCP area
• Experience in guiding and supporting colleagues
• Proven ability to manage several projects simultaneously within approved budgets, timelines, and quality requirements
• Curiosity and openness to evolving clinical research approaches, particularly Real-World Evidence and the use of artificial intelligence
• Proven ability to work independently, understand the scientific rationale of study protocols, and coordinate internal and external project contributors
• High level of initiative, reliability, diligence, team orientation, flexibility, and resilience
• Excellent written and verbal communication skills in English and German
• Confident use of Microsoft Office and Outlook

Ready to make an impact?

Bring your clinical operations expertise to an international environment and help ensure the successful delivery of high-quality clinical studies. We look forward to receiving your application via our career site.