We are currently seeking a dedicated Clinical Trial Manager / Clinical Operations Manager (m/f/d) for our renowned pharmaceutical client. In this 100% remote position, you will plan, manage, and oversee national and international clinical trials from feasibility studies to study completion. The position is initially offered through a temporary staffing agency until February 28, 2027, with the possibility of extension. We look forward to receiving your application! Operational Study Management: Independent planning, execution, and management of clinical trial activities in coordination with the COAD. Vendor & CRO Management: Management of external service providers (ESPs) to ensure timely and high-quality results. Study Documentation: Creation and review of key documents (e.g., study protocols, ICFs, manuals, safety and project plans). Sponsor & Monitoring Oversight: Implementation of GCP sponsor oversight plans and conducting oversight visits to trial sites. Quality & Risk Management: Identification, handling, and documentation of deviations in collaboration with CQA; conducting risk assessments. TMF Maintenance & Inspection Readiness: Quality control of the Trial Master File (TMF) to ensure ongoing audit and inspection readiness. Budget & IMP Tracking: Monitoring of the study budget (invoices, accruals) and support of IMP management (investigational medicinal products). Employment: 100% remote.
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Education: Successfully completed studies (Bachelor/Master) in Life Sciences (Biology, Pharmacy, Biochemistry) or a comparable qualification in the healthcare sector.
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Professional experience: Experience in clinical development in the pharmaceutical industry.
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Clinical Operations: Relevant prior experience directly in the field of Clinical Operations is desirable.
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GCP expertise: Sound and demonstrable knowledge of the ICH/GCP guidelines and the relevant international regulatory requirements for clinical trials.
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Process experience: Proven practice in risk management and TMF care .
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Soft skills: Strong analytical skills, a solution-oriented approach to work, assertiveness and negotiation skills.
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Language skills: Fluent German and English skills, both spoken and written.
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Clinical Trial Manager (m/f/d) in Holzkirchen Arbeitgeber: Gulp Ag
Als führendes, international tätiges Industrieunternehmen in Lengerich bieten wir Ihnen als Design Engineer (m/w/d) nicht nur ein attraktives Gehalt von bis zu 70.000 € jährlich, sondern auch 30 Tage Urlaub und hervorragende Möglichkeiten zur beruflichen Weiterentwicklung in einem stabilen Arbeitsumfeld. Unsere Unternehmenskultur fördert Teamarbeit und Flexibilität, sodass Sie in einem dynamischen Umfeld an spannenden Projekten arbeiten können, während Sie gleichzeitig die Qualität unserer Produkte durch Ihre technische Expertise sicherstellen.
