Job Description
Company Description
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description· 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 patient’s safety and well-being:
o Detection of trends and outliers
o Signal detection
o Eligibility check
o Review of selected laboratory parameters
o Protocol deviations review with proposed grading from medical/safety perspective
o Review of subject discontinuation list
o Monitoring of specific safety parameters (risks due to IMP or AxMP safety profile as well
as an indication)
· Medical review/creation of case/narratives and participating in the SAE reconciliation as support to the Safety Department
· Regular presentations of MM reports to the study team
· Medical Review of patient data
· Medical input to the study-related documents (including the preparation of the MM plan)
· Participation in Kick-off Meetings, Investigator Meetings, and other study-related meetings,
including participation at the safety committee meetings (DSMB, IDMC, and SRC meetings) andpresentation of the safety data
· Training of the project team and investigators on the indication, IMP, AxMP, and other medical aspects of the study
· Reviews or assists in the review of medical coding to assure congruency with the terms reported in the case report form (CRF) and provides re-coding of events if appropriate · Overview of SP activities and review of the SP visit reports
· Bid Defence meetings and interactions with the sponsor.
Qualifications
Additional Information
Why Ergomed
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
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