Clinical Medical Monitor

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver timely medical expertise for designated studies, encompassing eligibility, dosing, protocol specifications, safety incidents, and other study-related medical inquiries.

• Evaluate adverse events (AEs) and serious adverse events (SAEs), determining causality, severity, expectedness, clinical significance, and potential impacts on patients and the program.

• Address medical inquiries from investigators and sites, maintaining a balance between patient safety, protocol adherence, and clinical judgment.

• Analyze patient-level and aggregate clinical and safety data to spot trends, inconsistencies, emerging signals, and areas that necessitate follow-up.

• Ensure that medical monitoring, safety assessments, escalation procedures, and documentation comply with regulatory standards, Good Clinical Practice (GCP) guidelines, and study protocols.

• Collaborate with clinical development, clinical operations, safety/pharmacovigilance, biostatistics, data management, and regulatory teams.

• Employ independent medical judgment, challenge assumptions when necessary, and decide what and when to escalate issues.

⛳️ Requirements

• MD or an equivalent medical degree is required; experience in CNS or relevant therapeutic areas is preferred.

• Experience in clinical trials with responsibilities for medical monitoring, clinical safety, or related medical oversight.

• Strong clinical judgment with a proven ability to assess AEs and SAEs with consistency and rigor.

• Experience in addressing medical questions from investigators and sites, making timely decisions even when information is incomplete.

• Ability to review clinical data, identify significant patterns or potential safety signals, and determine when action or further surveillance is necessary.

• Familiarity with GCP, clinical trial safety reporting requirements, and documentation standards.

• Willingness and flexibility to travel as required.

• Comfort with screen work, basic hand coordination, clear communication, and focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-paid life insurance.

• Accidental Death & Dismemberment (AD&D) benefits.

• Disability benefits.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous Paid Time Off (PTO).

• Paid holidays.

• Company-wide shutdowns.