Central Review Manager

Thermo Fisher Scientific

. Perform centralized report review and approval of PSA, SI IMV, and CO reports on assigned projects in accordance with procedural documents and guidelines .

Posted 11/10/2026full-timeRemote • Mexico, BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and report review, ensuring compliance with FDA regulations, ICH GCPs, and CRG procedural documents. Proficient in evaluating site capability and mentoring junior team members while maintaining effective communication and organizational skills.

Highest-signal resume keywords

Clinical Research ExperienceFDA Regulations KnowledgeICH GCPs ComplianceClinical Monitoring Visit ReportsEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringReport ReviewMedical TerminologyRisk AssessmentData InterpretationMonitoring Report TemplatesProject ManagementForecast EstimatesSite Capability EvaluationRegulatory Compliance

Soft Skills

Organizational SkillsTime ManagementTeam CollaborationMentoring SkillsWritten Communication

Tools & Technologies

CTMSElectronic Study Data SystemsDashboards

Certifications & Qualifications

Clinical Foundation Training Program (CFP)

Industry Keywords

Life SciencesClinical TrialsProject TeamsRegulatory RequirementsAudit Responses

About the role

Key responsibilities & impact

Perform centralized report review and approval of PSA, SI IMV, and CO reports on assigned projects in accordance with procedural documents and guidelines
Review clinical monitoring visit reports for allocated projects, ensuring consistency across protocols and/or regions, and escalate protocol, site, CRA issues or trends to CL
Liaise with clinical monitoring staff for prompt trip report review submission and approval according to CRG and/or Sponsor timelines
Participate actively on project teams to help ensure compliance with monitoring visit report expectations
Review and customize Monitoring Report Templates for allocated projects
Evaluate PI oversight, subject safety, and study processes to assess site capability
Attend applicable internal Project meetings
Provide input of forecast estimates for report review activities
Track trial MVR status and provide progress updates to the team
Contribute to company, client, and federal/local regulatory requirements and audit responses
Perform agreed support activities for allocated projects

Requirements

What you’ll need

Bachelor’s Degree in a life science-related field or relevant/equivalent combination of education, training, and experience
Prior clinical research experience with a minimum of 2 years on site clinical monitoring
Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA
Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and CRG procedural documents
Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
Highly effective oral and written communication skills with the ability to communicate effectively with project team members
Excellent organizational and time management skills
Ability to work in a team or independently or as home based, as required
Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports
Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of all these data
Excellent English language and grammar skills
Ability to mentor junior team members, as needed