Associate Medical Director / Neurologist
A
AllucentClinical Trials
United StatesFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum 3 years of relevant work experience
- Required Skills
- Microsoft OfficeHIPAA
Requirements
- MD degree.
- Experience as a Neurologist.
- Minimum 3 years of relevant work experience.
- Strong Neurology expertise.
- Good knowledge of GxP.
- Good standing with local, state (in the US), and national licensing and regulatory authorities.
- Understanding of GDPR/HIPAA, CFR/CTR/CTD and applicable local regulatory requirements.
- Strong written and verbal communication skills in English.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
Responsibilities
- Independently provide medical monitor support to assigned clinical studies, including answering medical questions and interpreting protocols.
- Review clinical data, including lab results and case report forms, to ensure scientific validity and protocol adherence.
- Prepare Medical Monitoring and other relevant plans in accordance with study deliverables.
- Perform medical review of Serious Adverse Events (SAEs), SUSARs, and safety narratives.
- Assist with MedDRA and WHO coding, and review clinical trial documents such as CTP, ICF, CSR, and DSUR/PSUR reports.
- Participate in Data Safety Boards (DSMB/DMB) and dose escalation meetings.
- Provide 24/7 urgent medical and safety advice as required.
- Train project teams on the medical aspects of trials and therapeutic areas.
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