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Clinical Trial Manager

2 months, 1 week 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 20

Description

  • Oversee study scope, quality, timelines, and budget with internal leads, CROs, and vendors to meet project objectives.
  • Manage the operational execution of global clinical trial programs and ensure adherence to GCPs, SOPs, and regulatory guidelines.
  • Partner with CROs to develop and implement patient enrollment and ongoing data monitoring strategies.
  • Identify, assess, and manage study-related risks proactively.
  • Develop and manage clinical trial documents, including protocols, CRFs, and informed consents.
  • Review study plans and processes such as CTA, site budgets, statistical analysis plans, monitoring plans, data management plans, and safety monitoring plans.
  • Collaborate with Regulatory and CRO teams to support regulatory submissions.
  • Review CRO and vendor contracts, work orders, and technical specifications to align with study objectives.
  • Participate in system build reviews and user acceptance testing for tools such as IRT, eCOA, and EDC.
  • Manage data cleaning, database lock activities, essential document packages, TMF review, and inspection readiness.
  • Direct investigator performance, address protocol adherence issues, and resolve enrollment problems as needed.
  • Coach and oversee Clinical Trial Associates assigned to the project.

Requirements

  • Bachelor’s degree in life science or equivalent.
  • Minimum 5 years of clinical trial management experience in international clinical trials within a sponsor pharma or biotech organization.
  • Phase II and Phase III experience required.
  • Strong understanding of drug development, ICH guidelines, GCP, and the clinical trial process.
  • Proven experience overseeing complex studies managed 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.
  • Experience building relationships with KOLs and clinical site personnel.
  • Demonstrated ability to develop and deliver patient enrollment strategies.
  • Strong planning, time management, coordination, problem-solving, and judgment skills.
  • Excellent written and oral communication skills.
  • Ability to review and understand complex scientific concepts and clinical data.
  • Up to 35% travel required, including in-person attendance at Apogee All Hands meetings and travel for Phase 3 meetings, clinical sites, and medical conferences.
  • Biotech experience strongly preferred.

Benefits

  • Anticipated salary range of $145,000 to $160,000 per year.
  • Market-competitive compensation package including base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and dedicated paid sick leave.
  • Commitment to professional growth with access to development resources.
  • Opportunity to work in a fast-paced, highly dynamic environment.
  • Regular in-person all-team meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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