EDUCATION AND PROFESSIONAL EXPERIENCE/KNOWLEDGE:

• University degree in medicine, pharmacy, biology, biochemistry or related natural science
• Experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor or site-coordinator.
• Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate

SOFT SKILLS:

• Strong skills in project management
• Problem-solving and risk-management skills in a clinical study environment
• Data analytic skills and use of digital tools, platforms and systems
• Change management skills
• Interpersonal skills with ability to create and foster trustful relationships with several internal and and external stakeholders
• Willingness to travel ~ 10-20% (in-country)
  Languages: Fluent in English and German

MAIN RESPONSIBILITIES:

• Set Up Local Study Strategy: Develop and initiate recruitment and retention strategies, identify successful site mapping, and set up site engagement plans. Organize local kick-off meetings and lead set-up activities to ensure progress.
• Manage Study Execution: Own local study performance, ensure compliance with timelines, drive performance with risk assessment, manage site engagement, and support site staff. Represent CSU in Core Study Team meetings and escalate issues as needed.
• Optimize Study Budget: Collaborate on budget preparation, manage financial resources, and address budget-related issues promptly.
• Facilitate Communication: Act as the main link to the local monitoring team, collaborate with Vendor Functional Line Managers, plan and participate in engagement activities, coordinate local team meetings, and establish collaboration with Medical Affairs.
• Ensure Quality and Compliance: Maintain data quality, patient safety, and compliance with study metrics. Ensure CRA training, collaborate on audit activities, and ensure system readiness.