Beschreibung

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.

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)

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