Associate Medical Director / Oncologist
A
AllucentBiopharmaceuticals, Clinical Trials
CanadaFull-TimeMiddle
SalaryLe salaire de base pour ce poste commence à 110 000 $ CA.
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Job Details
- Languages
- English
- Experience
- At least three years of professional experience
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Doctor of Medicine (MD) degree
- Oncologist experience
- At least three years of relevant professional experience
- Strong expertise in oncology
- Knowledge of GxP standards
- In good standing with relevant local, provincial, and national regulatory and licensing authorities
- Understanding of applicable regulatory requirements including GDPR/HIPAA, CFR, CTR, and CTD
- Excellent written and verbal communication skills
- Proficiency in English
- Proficiency in Microsoft Word, Excel, and PowerPoint
Responsibilities
- Provide autonomous medical monitoring support for assigned clinical studies, including responding to medical queries and conducting medical review of clinical laboratory and case report data.
- Prepare medical monitoring plans and other relevant study documents prior to study initiation.
- Review serious adverse events, SUSARs, safety reports, and perform aggregate event analysis.
- Assist clinical data management teams with MedDRA and WHO coding for assigned trials.
- Contribute to the review of clinical study documents including CTP, ICF, CSR, DSUR, and PSUR for medical consistency and relevance.
- Support the establishment and operation of Data Safety Monitoring Boards (DSMB/DMB) and Dose Escalation Committees (DEC).
- Provide 24/7 emergency medical support for safety advice as needed.
- Identify study risks and contribute to the development of risk management plans.
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