Medical Monitor

cGxPServe Inc.; Boston (MA); On-site; USD 130,000 - 160,000; Full time

Job summary

cGxPServe, a leader in research services, seeks a Medical Monitor to drive safety in clinical trials within its Neuroscience team. This full-time role involves providing oversight on medical protocols, ensuring compliance, and supporting trial activities. Ideal candidates possess an MD/DO and have significant clinical monitoring experience, emphasizing independent work and communication skills.

Qualifications

• 2+ years clinical development experience conducting medical monitoring for clinical trials.
• Experience in later stage trials preferred.

Responsibilities

• Support the clinical development Neuroscience team with medical and safety monitoring.
• Medical monitoring and observation of clinical trials to ensure safety and adherence to protocols.
• Coordinate safety data communication with the study team.

Skills

Excellent communication

Interpersonal skills

Independent work

Education

MD/DO

Job description

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• 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.
• 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.
  
  

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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Research Services

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