Ihre Aufgaben

• Build the Clinical Operations structure and further develop existing SOPs and processes
• Establish and execute clinical development activities for an innovative biologic, including identification of process gaps and ensuring sponsor readiness for the first Phase I study
• Develop and implement GCP-compliant clinical trial management processes to support an efficient sponsor organization
• Create, optimize, and maintain GCP-relevant SOPs, work instructions, and templates
• Ensure operational readiness of clinical IT systems (CTIS, EudraVigilance, SPOR), including user management and compliance oversight
• Coordinate the development of key study documents such as the Protocol, Investigator’s Brochure, SAP, and the Clinical Study Report
• Lead CRO and vendor selection processes, including negotiation and contract management
• Oversee external service providers with regard to roles, timelines, quality, and budget, ensuring efficient collaboration among all partners

Ihre Qualifikationen

• Bachelor’s degree in Life Sciences (Biology, Medicine, Pharmacy, Biotechnology) or equivalent professional experience
• At least 5 years of experience in Clinical Operations / Project Management on the sponsor or sponsor-representative side
• Solid knowledge of clinical drug development and regulatory requirements (ICH-GCP, EU-CTR, FDA regulations)
• Proven expertise in vendor and CRO management as well as eTMF systems and clinical data processes
• Strong project management skills, including budgeting, resource planning, and stakeholder management
• High degree of autonomy, hands-on mentality, and enthusiasm for building new structures
• Pragmatic, resilient, and adaptable personality with openness to dynamic environments
• Willingness to travel and proficient use of MS Office 365
• Excellent English skills are required; German skills are a plus

Ihre Vorteile

• A key role in building the Clinical Operations structure with significant room for shaping and decision-making
• Direct impact on the clinical development of an innovative biologic, working closely with external partners in an agile, growth-oriented environment
• Flexible working hours and home office options within an open company culture with short decision-making paths
• Our client offers an annual gross salary starting from EUR 56,000 (excluding bonus), with a clear willingness to offer a higher package depending on qualifications and experience.