Clinical Medical Monitor
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Great clinical development depends on strong medical judgment in the moments that matter: when an investigator has a question, a safety event needs assessment, or emerging data require action.At Praxis, you’ll provide hands-on medical oversight for assigned clinical programs, with patient safety and study quality at the center. You’ll support investigators and sites on eligibility, dosing, safety events, and other medical questions; review clinical and safety data; assess serious adverse events; and identify emerging signals or trends.You’ll partner closely with clinical leads and cross-functional study teams while maintaining independent medical judgment. This is a role for someone who wants to stay close to the patients, sites, and data and make timely, thoughtful decisions that keep studies moving safely and effectively. Primary Responsibilities Medical oversight: Provide timely medical guidance for assigned studies, including eligibility, dosing, protocol requirements, safety events, and other study-related medical questions. Clinical safety assessment: Review AEs and SAEs, assessing causality, severity, expectedness, clinical significance, and potential implications for patients and the program. Site support: Respond promptly and consistently to investigator and site medical questions, balancing patient safety, protocol requirements, and sound clinical judgment. Data surveillance: Review patient-level and aggregate clinical and safety data to identify trends, inconsistencies, emerging signals, and areas requiring follow-up. Safety and regulatory compliance: Ensure medical monitoring, safety assessment, escalation, and documentation meet applicable regulatory requirements, GCP standards, and study protocols. Cross-functional partnership: Work closely with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory colleagues to resolve issues and support high-quality study execution. Independent judgment: Bring a clear medical perspective to decisions, challenge assumptions when warranted, and know what to escalate and when. Qualifications and Key Success Factors MD or equivalent medical degree required; CNS or relevant therapeutic area experience preferred. Clinical trial experience with responsibility for medical monitoring, clinical safety, or related medical...
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