FR
Fresenius Kabi Deutschland GmbH
2 Monate

Senior Manager Clinical Operations(m/w/x)

Vollzeit
Senior
Keine Angabe
Bad Homburg vor der Höhe

In this role, you will oversee the planning and execution of clinical trials, ensuring compliance with regulations while collaborating with various teams and external partners. Your day-to-day responsibilities will include managing project timelines, budgets, and documentation to support successful study outcomes.

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Anforderungen

  • •Master’s degree in life sciences, pharmacy, or related field
  • •At least 5 years of experience as clinical trial manager
  • •Hands-on experience with project management tools or certification
  • •Strong knowledge of GCP, ICH guidelines, and regulatory requirements
  • •Proficiency in Microsoft Office tools
  • •Excellent project management skills
  • •Ability to work effectively in international teams
  • •Excellent communication skills, spoken and written (English)
Master-Abschluss
ODER
Doktor / Ph.D.

Berufserfahrung

5 Jahre

Deine Aufgaben

  • •Plan and organize national and international clinical trials
  • •Execute and oversee clinical trials focusing on nutrition studies
  • •Manage clinical studies according to EU, US, and PhM requirements
  • •Develop detailed project plans, timelines, and budget estimates
  • •Select, instruct, and supervise Contract Research Organizations (CROs)
  • •Collaborate with external service providers, including consultants and medical experts
  • •Engage in cross-functional collaboration with Regulatory Affairs and Drug Safety teams
  • •Design and develop clinical study protocols and case report forms (CRFs)
  • •Review clinical study reports and analytical method validation documents
  • •Compile regulatory documents, including clinical trial applications and amendments
  • •Respond to queries from regulatory authorities and ethics committees
  • •Ensure compliance with regulatory requirements and standards
  • •Monitor and supervise study sites to ensure data integrity
  • •Set up and maintain the trial master file (TMF)
  • •Safeguard study documentation
  • •Generate monthly status reports for internal reporting

Tools & Technologien

Microsoft Officeclinical trial management software

Sprachen

Englisch – verhandlungssicher

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