Medical Monitor

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.

The Medical Monitor is responsible for providing medical oversight during the conduct of clinical studies (ranging from single-center to multi-center, multinational studies) managed by bioskin, the goal being to ensure the safety and clinical integrity of participating subjects/patients.

Principal Responsibilities and Duties:

Ongoing review of laboratory and ECG alerts

Medical expertise and guidance for project team and clinical sites regarding subject/patient eligibility and safety issues and any protocol-related medical questions during study conduct

Safety review of AEs/SAEs

Review of medical data listings including vital signs, concomitant medication, medical history, laboratory data, amongst other data

Medical assessment of protocol deviations

Participates in project team meetings and medical team meetings and serves as medical interface between sponsors and clinical site teams.

Qualifications & Skills:

MD licensed in Germany, preferably with specialization in dermatology

Basic knowledge of clinical research and ICH-GCP required, previous experience

in medical monitoring an additional asset

Very good English and German (both written and spoken)

Proactive working style, strong teamworking and communication skills

Analytical skills and close attention for detail

Working time 20 – 30 hours per week

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Originally posted by Eurofins. View original posting

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