Medical Monitor / Medical Monitor Trainer

Length of Assignment: 1 year

Location: Preferred location is Lake County, IL. Other options include Florham Park, NJ; South San Francisco, CA; or Remote. Candidates working remotely or outside Lake County may be required to travel to Lake County monthly.

The Medical Monitor / Medical Monitor Trainer leads the direction, planning, execution, and interpretation of clinical trial data for one or more early-phase clinical development programs, with potential support for late-phase programs as capacity allows.

This role provides medical monitoring oversight, supports safety and efficacy data review, and delivers structured training to Scientific Directors and Medical Directors involved in early- and/or late-stage oncology development. Training will focus on clinical data review, medical monitoring techniques, and the use of key data review tools and platforms.

• Lead training for Scientific Directors and Medical Directors in early- and/or late-phase oncology development on clinical data review and medical monitoring best practices.
• Design and deliver live and/or virtual training sessions ranging from foundational to advanced topics, including:
  
  
  
  • Roles and responsibilities of the Scientific Director, Medical Director, CRO, and other cross-functional reviewers.
  • Data review within EDC systems, including query generation, query resolution, and follow-up.
  • Review of listings, patient profiles, aggregate data, integrated data panels, Spotfire, J-Review, and related platforms.
  • Data-cleaning metrics and identification of trends requiring action.
  • TLF review and interpretation.
  • Dose-escalation review and data interpretation in early-phase oncology studies.
  
  
  
  
• Develop, oversee, and/or review accurate CRF Completion Guidelines (CCGs), medical review guidelines, and medical monitoring plans for Client and/or CRO-managed studies.
• Review, interpret, and communicate accumulating safety, tolerability, and efficacy data for assigned molecules and studies.
• Provide medical monitoring oversight for ongoing trials, including identification, assessment, and follow-up of important clinical and safety findings.
• Serve as a key reviewer of serious adverse events, supporting timely assessment, documentation, and escalation as appropriate.
• Review patient narratives for completeness, accuracy, and medical relevance.
• Identify data inconsistencies, trends, or emerging safety signals and communicate findings to study teams and stakeholders.
• Collaborate with clinical scientists, clinicians, biostatisticians, data management, pharmacovigilance, regulatory, and CRO partners to ensure high-quality data review and issue resolution.
• Support study team readiness for internal and external data review meetings, safety review meetings, and dose-escalation discussions.
• Contribute to the development of training materials, job aids, and standardized review guidance for Medical Monitors and Scientific Directors.
• Mentor team members on effective data review practices, medical judgment, and interpretation of clinical trial data.
• Maintain awareness of protocol-specific risks, stopping rules, escalation criteria, and monitoring plans.
• Ensure timely escalation of clinically significant issues and support decision-making related to participant safety and study conduct.

• Advanced clinical degree preferred; other advanced scientific or medical degrees may be considered depending on scope.
• Experience in clinical development, medical monitoring, oncology trials, or clinical data review in early-phase and/or late-phase settings.
• Strong understanding of clinical trial operations, safety review, adverse event assessment, and data-cleaning processes.
• Experience with EDC systems, listings review, patient profiles, safety dashboards, and clinical review platforms such as Spotfire and J-Review.
• Demonstrated ability to train, mentor, and communicate complex clinical information clearly to scientific audiences.
• Strong collaboration, judgment, and problem-solving skills.
• Familiarity with oncology development, dose escalation, and translational or biomarker-driven studies is preferred.