Study Start-Up Specialist

• Responsible for start-up activities in Germany and Austria and provides local expertise
• Identify gaps and areas for improvement and propose CAPA
• Collaborate with the Regional Clinical Study Manager/Start-up Lead to ensure study timelines and quality standards
• Provide country-specific study start-up expertise and support budget and contract negotiations
• Follow or support AMG or GCP-V requirements under German/Austrian laws
• Retrieve essential documents and perform essential document site file reconciliation
• Perform independent quality review of submission packages and submit packages to EC/HA or support CTIS submission
• Review and translate drug labels, ICF, site-specific recruitment materials, and other applicable documents
• Manage sites and site performance by tracking regulatory submissions and milestones
• Ensure inspection readiness of start-up study and site documentation
• Collaborate with clinical study sites to deliver start-up milestones on time
• Evaluate site practices and escalate quality or GCP issues
• Anticipate and identify site issues; propose corrective and preventative actions
• Initiate, support, or lead process improvement initiatives
• Promote operating excellence, innovation, and continuous improvement

• BS or equivalent in a relevant scientific discipline
• Experience in oncology global trials preferred
• Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines
• 2-5 years of Start-up experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multitask
• Fluent in German
• English writing and speaking
• Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook
• Willingness to travel up to 15%

• Equal opportunity employment
• Travel up to 15%