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Clinical Monitoring Manager

1 hour, 39 minutes ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 14

Description

  • Oversee in-house CRAs and ensure study deliverables are completed efficiently, with quality, and in compliance with SOPs, regulations, GCP, KPIs, and study-specific requirements.
  • Support the hiring, training, and development of in-house CRAs and maintain study training compliance.
  • Develop and implement project-specific processes, tools, and documents such as monitoring oversight plans, site visit report templates, and monitoring tools.
  • Review monitoring visit reports and metrics, identify compliance trends and protocol deviations, escalate issues, and support corrective and preventive actions.
  • Oversee CRA review of clinical data from EDC, eCOA, central lab, and risk-based monitoring outputs to ensure data quality and integrity.
  • Ensure sites remain inspection-ready, including Trial Master File readiness for health authority inspections.
  • Lead regular meetings with in-house and CRO CRA teams to communicate updates, best practices, and performance expectations.
  • Monitor CRA team performance, implement action plans as needed, and escalate performance issues to Clinical Operations leadership.
  • Conduct or oversee field monitoring activities including qualification, initiation, interim monitoring, and close-out visits.
  • Support site and investigator identification, liaise with clinical site personnel, and coordinate site audit readiness and issue escalation.

Requirements

  • Bachelor's degree in a scientific or healthcare-related field.
  • Minimum 8 years of experience as a CRA or in a related role within the pharmaceutical, biotechnology, or medical device industry.
  • Minimum 2 years of experience leading a team of CRAs.
  • Recent experience in respiratory, dermatology, and/or gastrointestinal clinical trials preferred.
  • Certification as a Clinical Research Associate (CCRA) or equivalent preferred.
  • Recent experience using risk-based monitoring models.
  • Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), and FDA regulations.
  • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet.
  • Experience with EDC systems, eTMFs, and other clinical trial databases and systems.
  • Strong understanding of clinical trial processes and study conduct.
  • Excellent organizational, time management, communication, and interpersonal skills.
  • Ability to work collaboratively, independently, and in a fast-paced, dynamic environment.
  • Ability to travel up to 35%, including required in-person attendance at Apogee All Hands meetings and Phase 3 meetings, plus U.S. and international travel to sites or conferences.

Benefits

  • Anticipated base salary of $150,000 to $170,000 per year.
  • Market-competitive compensation package including performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to growth resources.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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