Beschreibung
Trial Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Responsible for supporting the operational management and oversight of clinical trials within assigned countries/regions
- Work closely with CDO trial team to support clinical trial-related activities at the country/site level (site initiations and closures, import/export licenses, Trial Master File [TMF], contracts, and invoices)
- May participate in the selection of EPSs and training of ESP Personnel
- Contribute to the completion of ESP scope documents and applicable ESP documents (e.g., lab manuals)
- Oversee performance of ESPs on a global level to ensure compliance with the clinical study protocol and in accordance with the scope of work (SoW)
- May assist in the preparation for audits/inspections and implementation of Corrective Action
- Preventive Action (CAPA) plans
- May provide input into the development of Clinical Study Report
- Ensure compliance of all activities in accordance with the clinical study protocol, ICH-GCP, local
- Regulations and Quality System documents
- Oversee adherence to legal, regulatory, and ethical standards and guidelines, including Serious Adverse Event reporting
Main qualifications
- A degree in natural sciences as well as profound experience in managing phase II and III trials in a global environment
- Detailed understanding of IHC/GCP procedures and regulations and experience with initiations and closures, import/export licenses, trial master file, contracts and invoices
- Knowledge of managing clinical external service providers and an outstanding command of English in both verbal and written form
Main advantages:
- A highly motivated team and an open way of communication
- An attractive remuneration package awaits you
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Sevda Karakas
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