Medical Monitor
Medical Monitor
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
ROLE AND RESPONSIBILITIES
- 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 well-being:
- 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 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) and
- Presentation 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
Qualifications :
QUALIFICATIONS
- Medical Doctor degree. Additional board certification and/or medical specialty are appreciated and optional.
- Practical clinical research experience
- Highly organized with strong interpersonal skills
- Proven efficiency in timely delivery
- Proficiency in all MS Office applications including Microsoft Word Excel and PowerPoint Practical use of Microsoft Teams and SharePoint is needed
Additional Information :
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.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- Environmental Safety
- Fashion Retail
- C++
- Arabic Faculty
- BI
