Senior Manager Clinical Operations (m/f/d)

Fresenius SE & Co. KG aA; Bad Homburg vor der Höhe; On-site; EUR 90,000 - 130,000; Full time

Job summary

Fresenius SE & Co. KG aA in Germany seeks a Senior Manager Clinical Operations to lead international clinical studies, align internal teams and CROs to meet quality, timelines and budgets.

You will develop protocols, oversee trial master file, manage investigator and DSMB meetings, and ensure regulatory compliance while advancing Real-World Evidence and AI approaches.

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

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

Skills

Project management

Stakeholder management

Team leadership

Multitasking

Bilingual EN/DE

Education

Science degree (biology/biochemistry/pharma/nutrition)

Tools

Microsoft Office

Outlook

Job description

About us

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

What we offer

Bring your clinical operations expertise to an international environment and help ensure the successful delivery of high-quality clinical studies.