Sr. Medical Monitor (extensive oncology experience required)

Raleigh, WV - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

ROLE AND RESPONSIBILITIESMedical guidance to site personnel and the project team regarding Protocol and other study-specific medical aspects24/7 medical consultancy support to investigators and project teamMonitoring of patients safety and well-being: Detection of trends and outliers Signal detectio...

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

Key Skills

Hospital Experience
Acute Care
Basic Life Support
ICU Experience
Infusion Experience
Triage
TFS
Conflict Management
Nursing
Critical Care Experience
Epic
Medication Administration

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About Company

Ergomed

Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more

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