Medical Monitor

cGxPServe; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading company in clinical development seeks a Medical Monitor to support the Neuroscience team. The role entails overseeing medical monitoring, reviewing safety data, and ensuring compliance during clinical trials. Ideal candidates will have an MD/DO with experience in clinical development and excellent communication skills.

Qualifications

• 2+ years clinical development experience conducting medical monitoring.
• Experience with later stage clinical trials preferred.
• Excellent communication and interpersonal skills.

Responsibilities

• Support the Neuroscience team with medical monitoring and safety.
• Review safety data and assess Serious Adverse Events (SAEs).
• Conduct literature reviews and coordinate safety studies.

Skills

Communication

Interpersonal Skills

Medical Monitoring

Independence

Education

MD/DO

Job description

Responsibilities

• Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.
• Provides medical monitoring and observation of clinical trials to ensure safety and adherence to protocol.
• Coordinates, conducts, and communicates overview of safety data and significant changes to the study team.
• Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs).
• Responsible for medical monitoring of assigned studies including data reviews, queries assigned in TESLA.
• Participates in Product Safety Team meetings.
• Reviews CSRs/IBs/submissions, etc.
• Peer review draft DRC materials.
• Monitor and compile competitive intelligence (landscape) assessments/white papers and provide medical perspective/implications.
• Assesses start-up requirements for EDC to ensure studies are set up properly for medical monitoring in collaboration with the study team.
• Conducts literature reviews at the request of study teams.
  
  

Requirements

• MD/DO with 2+ years clinical development experience conducting medical monitoring for clinical trials.
• Medical Monitoring experience (later stage trials preferred).
• Excellent communication and interpersonal skills.
• Ability to work independently.