Company Description
eurofins bioskin is a leading niche CRO with unique understanding and capabilities for both early and late phase development of dermatological and related products. Since its inception in 1992, eurofins bioskin has been recognized as a valuable partner for dermatological product development. Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, eurofins bioskin has grown into a full-service CRO offering global dermatologic consulting and regulatory services and all services for management of Phase I-IV drug trials and claim support/safety studies. eurofins bioskin is headquartered in Hamburg, Germany.We are looking for an experienced Clinical Research Associate (CRA) /Lead CRA for our CRA team at Eurofins bioskin in Hamburg. The senior CRA will manage all aspects of clinical monitoring to ensure quality, compliance and oversight to applicable regulations.
Focus of tasks:
- Coordinate team of CRAs
- Co-Monitoring, training and support of junior or freelance CRA team (in-house and freelance CRAs)
- Act as a CRA and Lead CRA for defined project(s) , i.e. performing on-site monitoring (including site selection, initiation, periodic and close out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-III
- Close cooperation with internal interface departments and external stakeholders
- Giving input to financial proposals for monitoring activities
- Represents bioskin in bid defenses and investigator meetings
- Identify and implement possible improvements to current processes, determine new processes that are needed
Job Description
We are looking for an experienced Clinical Research Associate (CRA) /Lead CRA for our CRA team at Eurofins bioskin in Hamburg. The senior CRA will manage all aspects of clinical monitoring to ensure quality, compliance and oversight to applicable regulations.
Focus of tasks:
- Coordinate team of CRAs
- Co-Monitoring, training and support of junior or freelance CRA team (in-house and freelance CRAs)
- Act as a CRA and Lead CRA for defined project(s) , i.e. performing on-site monitoring (including site selection, initiation, periodic and close out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-III
- Close cooperation with internal interface departments and external stakeholders
- Giving input to financial proposals for monitoring activities
- Represents bioskin in bid defenses and investigator meetings
- Identify and implement possible improvements to current processes, determine new processes that are needed
Qualifications
Profile:
- Degree in a scientific or medical discipline
- 5 years of industry experience working on clinical trials/investigations and at least 2 years of experience as CRA in leading position are imperative, ideally including multicenter and multinational trials
- Open to travel, including overnight stays
- Advanced knowledge of, and ability to, apply GCP/ICH, ISO 14155 and all applicable regulatory guidelines
- Fluent in German and English (written and spoken)
- Well-structured and organized, target-oriented personality, must work both independently and in a team environment
- Capability to communicate complex issues clearly
- Candidates with experiences in the indication dermatology will be preferred
- Home office based work is possible (at least partially office-based work in Hamburg preferred)
Additional Information
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your complete application including your anticipated salary to:
Bitte senden Sie Ihre vollständige E-Mail-Bewerbung als PDF-Datei mit Gehaltsvorstellung an:
bioskin GmbH • Messberg 4 • 20095 Hamburg Bettina Möhlenbrock • Email: SM_bioskin-recruitment@cpt.eurofinseu.com
Please send applications by e-mail as pdf file.
