Senior Manager Clinical Operations (m/f/d)

Fresenius Kabi USA; Bad Homburg vor der Höhe; On-site; EUR 90,000 - 130,000; Full time

Job summary

Fresenius Kabi USA is seeking a Senior Manager Clinical Operations (m/f/d) to lead national and international clinical studies, coordinating internal teams and external partners to ensure study quality and strategic alignment.

You will manage timelines, budgets, and regulatory compliance (ICH-GCP), prepare protocols, oversee CROs, DSMBs, and site activities, and contribute to audits, CAPAs, and study results publications.

Qualifications

• University degree in natural sciences or related field.
• Minimum five years in PM or CTM in GCP.
• Ability to guide colleagues and manage multiple projects within budgets and timelines.
• Interest in Real-World Evidence and AI in clinical research.
• Fluent English and German communication skills.

Responsibilities

• Plan, organize, conduct, oversee, and evaluate national and international single-center and multicenter clinical studies per ICH-GCP and SOPs.
• Obtain and review CRO proposals, and oversee CROs and external providers.
• Prepare study protocols, CRFs, and final reports; manage study databases.
• Maintain Trial Master File and select study sites/DSMB members.
• Coordinate investigational product supply and communicate with authorities.
• Prepare for audits/inspections and implement CAPAs.
• Take responsibility for cost planning, budgeting, and monthly study status reporting.
• Contribute to SOP updates and dissemination of study results; participate in congresses.

Skills

Project management

Clinical trial management

Team leadership

Budgeting

Regulatory knowledge (ICH-GCP)

English & German communication

Education

Bachelor degree in natural sciences

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