Founded in 1997 by two Medical Doctors, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in executing complex trials for  new Rare Disease, Oncology and Neuroscience treatments.

Due to our continued growth within our Global Medical Affairs Group we are seeking a Medical Monitor.

The Medical Monitor within the ERGOMED Medical Monitoring Group is responsible for providing medical monitoring and medical safety expertise and guidance to the study site and project teams. 

The main responsibilities of Medical Monitor are providing:

Medical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects

24/7 medical consultancy support to investigators and project team

Monitoring of patients‘ safety and wellbeing:

Detection of trends and outliers

Signal detection

Eligibility check

Review of selected laboratory parameters

Protocol deviations review with proposed grading from medical/safety perspective

Review of subject discontinuation list

Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well as indication)

Medical review/creation of case/narratives and participating in the SAE reconciliation as support to Safety Department

Regular presentations to the study team of MM reports

Quality Check of the Medical Review

Additional duties and responsibilities of Medical Monitor are providing:

· Regular monitoring of crucial/critical endpoint parameters

· Medical input to the study related documents

· Participation at Kick-off Meeting, Investigator Meeting and other study related meetings

· Training of the project team and investigators on the indication, IMP, AxMP and other medical aspects of the study

· Additional Medical Data Review, as agreed with the sponsor in the Scope of Work:

Review of all or critically relevant data for consistency, coherency, reliability and medical “logic”

Ensure that critical endpoint parameters are met according the protocol

Ensures that the data make medical sense and the Protocol is demonstrated to have been followed by the site

Final MDR which may cover the review of data interpretation and publications

MD degree

Demonstrated experience in clinical research in CRO or pharma

English advanced/fluent level

Excellent communication skills oral and written and proven, efficient medical communication

Proven efficiency in timely delivery

Remote work experience is necessary

Practical clinical research experience

Highly organized, with great interpersonal skills

Why Should You Apply?

• You want  be involved in a wide range of interesting projects and studies
• You want your  achievements  and hard work to be recognized
• You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
• You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both

All your information will be kept confidential according to EEO guidelines.