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Clinical Trial Manager

3 hours, 16 minutes ago
United States
Full-time
Senior
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 5

Description

  • Oversee operational management and execution of global clinical trial programs across Phases I-III.
  • Ensure compliance with GCPs, SOPs, and applicable regulatory agency guidelines.
  • Partner with CROs and third-party vendors to meet milestones, deliverables, quality standards, and timelines.
  • Oversee study scope, quality, timelines, and budget with internal leads, CROs, and vendors.
  • Build relationships with key opinion leaders and clinical site staff.
  • Partner on patient enrollment strategies and ongoing data monitoring plans.
  • Proactively identify and manage study risks and resolve routine issues.
  • Develop and manage clinical trial documents, including protocols, CRFs, consents, and related study plans.
  • Support regulatory submissions and review CRO/vendor contracts, work orders, and system specifications.
  • Participate in UAT, data cleaning, database lock activities, TMF review, and site activation readiness.
  • Direct investigator performance, protocol adherence, and site issue management.
  • Coach and oversee Clinical Trial Associates supporting the project.

Requirements

  • Bachelor’s degree in a life science field or equivalent.
  • Minimum of 5 years of clinical trial management experience in international trials within a sponsor pharma or biotech organization.
  • Prior Phase II and Phase III experience required.
  • Strong understanding of drug development, ICH guidelines, GCP, and the clinical trial process.
  • Proven experience managing complex studies both in-house and through CROs.
  • Experience selecting and managing clinical vendors to support study activities.
  • Ability to lead teams and work effectively in a fast-paced, cross-functional environment.
  • Demonstrated ability to build patient enrollment strategies and relationships with KOLs and site personnel.
  • Strong planning, time management, coordination, problem-solving, and judgment skills.
  • Excellent written and oral communication skills.
  • Ability to review and comprehend complex scientific concepts and clinical data.
  • Up to 35% travel required, including in-person All Hands meetings, Phase 3 meetings, and travel to clinical sites or conferences.
  • Biotech experience strongly preferred.

Benefits

  • Anticipated salary range of $145,000 to $160,000 per year.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Access to resources for professional development.
  • Opportunity to work in a fast-paced, highly dynamic environment with exposure to multiple responsibilities.
  • Regular all-team in-person meetings to build relationships and collaborate.

Interested in this position?

Apply directly on the company website

Apply Now

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