RemoteLeaf Logo
Log in Sign up

Clinical Monitoring Manager

2 months, 1 week 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 20

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

Similar Roles

Real Chemistry

Project Manager, Promotional Medical Education

Real Chemistry 1K-5K Professional Services

Real Chemistry is hiring a Project Manager for its Promotional Medical Education team to lead healthcare marketing projects from planning through delivery across cross-functional agency and client teams.

United States Full-time Mid Level Project Manager
$70k-$85k
5 hours, 11 minutes ago
Anduril Industries

Deployment Lead, PACOM

Anduril Industries 1K-5K Aerospace & Defense

Anduril Industries is hiring a Mission Operations Deployment Lead to deliver, sustain, and continuously improve CUAS capability for defense customers in field environments.

Japan Full-time Senior Program Manager Project Manager
$112k-$149k
Computer Vision CRM
5 hours, 26 minutes ago
Olsson

NEPA Specialist (Transportation/FRA)

Olsson 1K-5K Construction & Engineering

Olsson is seeking an Environmental and Permitting Specialist to lead environmental review, permitting, and compliance work for complex transportation projects while coordinating with clients, agencies, and project teams.

Anywhere Full-time Senior Project Manager
$79k-$120k
5 hours, 41 minutes ago
Avalere Health

Account Supervisor (Pharma Agency)

Avalere Health Professional Services

Avalere Health is hiring an Account Supervisor to manage digital pharmaceutical brand accounts, with a focus on website work and CIDP, while serving as a client-facing partner and coordinating cross-functional delivery.

United States Full-time Senior Marketing Manager Project Manager
$100k-$112k
Agile Digital Marketing
5 hours, 41 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers