Clinical Project Leader - Chur, Schweiz - Hamilton Company

Hamilton Company

Geprüftes Unternehmen

Chur, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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: