Our client, Orpha Trade, is a small and agile pharmaceutical company headquartered in the heart of Vienna. The company specializes in the development and commercialization of innovative medicinal products and is currently experiencing a dynamic growth phase. With efficient structures, short decision‑making paths, and a high degree of autonomy, Orpha Trade is preparing to launch a Phase I study for a novel biologic. The company culture is characterized by pragmatism, openness, and strong individual accountability. This role offers the opportunity to build Clinical Operations from a greenfield setup and to significantly shape the clinical development program. To strengthen the R&D team, we are seeking an experienced, hands-on professional who assumes operational responsibility while also contributing strategic input.
(Senior) Clinical Operations & Project Manager (w/m/x)
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
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
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.
ARE YOU INTERESTED?
We are looking forward to receiving your application (English CV & cover letter incl. salary expectations) over the application-dashboard. Our responsible consultant will contact you immediately after receipt.
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