Associate Medical Director / Oncologist
A
AllucentClinical Trials
United StatesFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum 3 years
- Required Skills
- Microsoft ExcelHIPAA
Requirements
- MD degree.
- Specialization as an Oncologist.
- Minimum 3 years of relevant work experience in oncology.
- Strong knowledge of GxP standards.
- Current good standing with local, state, and national medical licensing and regulatory bodies.
- Understanding of GDPR, HIPAA, CFR, CTR, and CTD regulatory requirements.
- Strong written and verbal communication skills with proficiency in English.
- Proficiency with Word, Excel, and PowerPoint.
Responsibilities
- Independently provide medical monitor support to assigned clinical studies, including answering medical questions and assisting with protocol interpretation.
- Perform medical review of clinical data, including laboratory data and case report forms, to ensure protocol adherence and data validity.
- Prepare Medical Monitoring plans and review study documents such as clinical trial protocols (CTP), Informed Consent forms (ICF), and study reports (CSR).
- Monitor Serious Adverse Events (SAEs), SUSARs, and safety narratives, and perform analysis of similar events.
- Support clinical data management with MedDRA and WHO coding and assist in the setup of Data Safety Monitoring Boards (DSMB/DMB) and dose escalation meetings.
- Train project teams on medical aspects of trials and therapeutic areas.
- Provide 24/7 urgent medical and safety advice when required.
- Identify study risks and contribute to client evaluations and bid defenses.
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