Senior Manager Clinical Operations(m/w/x)

Requirements

• 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)

Tasks

• 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

Work Experience

Education

Languages

Tools & Technologies