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Clinical Monitoring Manager

3 weeks, 6 days ago
United States
Full-time
Lead
Project Manager
Project and Program Management
GCP
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 22

Description

  • Oversee in-house CRAs and ensure study deliverables are met with quality, efficiency, and compliance.
  • Serve as the primary liaison between Apogee, in-house CRAs, CRO clinical monitoring teams, and clinical study sites.
  • Support planning, management, and execution of Apogee-sponsored clinical trials with the study team.
  • Develop, implement, and improve study documents, monitoring plans, templates, tools, SOPs, and departmental processes.
  • Train, develop, and monitor compliance for in-house CRAs and lead regular team meetings to share updates and best practices.
  • Review monitoring visit reports, metrics, protocol deviations, and follow-up items, and escalate issues as needed.
  • Oversee CRA review of clinical data to ensure data quality, integrity, and completeness.
  • Ensure sites remain inspection-ready, including maintenance of the Trial Master File and readiness for health authority inspections.
  • Conduct or oversee co-monitoring, site qualification, initiation, interim monitoring, and close-out visits as needed.
  • Review and approve timesheets and expense reports, and assist with site and investigator identification when needed.

Requirements

  • Bachelor's degree in a scientific or healthcare-related field.
  • Minimum 8 years of experience as a CRA or in a related role in 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.
  • Clinical Research Associate (CCRA) certification or equivalent preferred.
  • Recent experience with 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, electronic TMFs (eTMFs), and other clinical trial databases and systems.
  • Up to 35% travel required, including travel to Apogee All Hands meetings, Phase 3 meetings in San Francisco, and domestic/international clinical sites or conferences.

Benefits

  • Anticipated base salary of $150,000 to $170,000 per year.
  • Market-competitive compensation package with performance bonus opportunities.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to growth resources.
  • Opportunity to work in a fast-paced, highly dynamic environment with regular in-person team meetings.

Interested in this position?

Apply directly on the company website

Apply Now

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