Clinical Project Leader
vor 3 Wochen
Company / Business Unit:
Hamilton Medical AG
- more information
**Responsibilities**:
- Project management responsibility of designated clinical trials, animal, and bench studies- Management of clinical trial sites- Direct involvement in developing and maintaining study documentation- Oversee and manage clinical study related regulatory submission/documentation, e.g.: Ethical Committee and Competent Authority submissions- Manages CRO relationship (including statistical and data management service providers) to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget- Create and oversee the trial budget- Ensuring and coordinating effective information exchange between the clinical team members, regulatory and engineering teams- Keeping a close contact with study investigators and sites- Support and review of draft publications for peer reviewed journals- Travel up to 25% in Europe and internationally
Qualifications:
You should bring along the following qualifications:
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or medical device development- Strong knowledge of Medical Device Regulation- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority medical device research & development regulations- Experience in managing and interacting with external clinical service providers like CRO, statistical service providers, clinical data management service providers- Fluent speaking, reading and writing in English- Highly structured, systematic, organized, & concise in communication (both written and spoken)
These qualifications would give you an advantage:
- Advanced degree (Master, PhD, MD) is desirable- Any critical care medicine and clinical environment experience- Knowledge of FDA regulation (21 CFR Part 812 and 510K)- Good written and spoken German skills (level B2)- Vigilance and Risk Management experience
If you have any questions, please do not hesitate to contact
with the following details:
Reference: JR-2918/Contact: Sina Bandli
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