Quetzal Therapeutics · 4 hours ago
Clinical Trial Manager
Chicago, IL
Full-time
Hybrid
Mid, Senior Level
4+ years expQuetzal Therapeutics is dedicated to transforming the future of medicine by addressing unmet medical needs in oncology and rare diseases. They are seeking a detail-oriented Clinical Trial Manager to oversee the day-to-day clinical operations for clinical trials, ensuring compliance with quality standards and timelines. The role involves collaboration with various functional groups, vendor management, and development of clinical study plans.
BiopharmaHealth CareMedical
Responsibilities
Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a complex environment in accordance with quality, ICH/GCP standards and following HIPAA/GDPR guidelines with minimal oversight
Work closely with various functional groups to support all aspects of clinical studies
Assist with CRO and/or vendor oversight and management to ensure milestones are achieved and document oversight from a sponsor’s perspective
Proactively identify issues in vendor performance and implement corrective actions
Supports/Leads the development and review of clinical study plans (Clinical Monitoring Plans, Data Management Plans, Safety Management Plans, Communication Plans, etc.), and other project/study-related documents including training materials, informed consent forms, logs, presentations, etc
Assist in site identification, qualification and feasibility assessment
Negotiate site contracts and budgets independently to align with budget parameters set for the trial
Review trip reports and follow through findings to resolution, study budgets and forecasting as needed
Develop and manage internal trackers to ensure all data remains updated
Support EDC database builds and data review
Responsible for ongoing review/oversight/filing of TMF and other records as assigned
Manages clinical monitoring activities, site/CRA training, overall site performance, tracking study metrics/KPIs and ensures compliance with Good Clinical Practices (GCP) and applicable regulations
Manage and support investigational product forecasting, accountability, data reconciliation
Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings as required
Assist with department compliance and performance initiatives and SOP writing
Other duties as assigned
To be successful in this role, the Clinical Trial Manager will be required to:
Develop and maintain strong internal and external relationships with key stakeholders
Ensure alignment for decisions/recommendations that require cross-functional input and that have cross-functional implications
Adapt quickly to evolving needs of the study
Maintain all applicable study logs in support of the study
Quickly and accurately identify issues and propose and implement effective solutions
Prospectively identify risks to leadership and mitigation approaches and implement them as appropriate
Qualification
Required
4+ years in clinical operations within pharma/biotech
Proven track record of managing vendors and delivering studies on time and within budget
Strong command of FDA regulations, ICH/GCP guidelines, and SOPs
BS or MS degree in life sciences or related field
Comfortable with ~20% travel
Preferred
Oncology experience strongly preferred
Benefits
Opportunity to contribute to meaningful work that impacts patients and their families.
Hands-on experience in biotech/clinical research, advocacy, and marketing.
Collaborative, mission-driven team environment.
Professional growth and career development opportunities.
Company
Quetzal Therapeutics
Quetzal Therapeutics is a biopharmaceutical company that develops new medicines for cancer and rare diseases.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Usman Ahmed
Chief Executive Officer
Recent News
Quetzal Therapeutics
2025-12-02
Quetzal Therapeutics
2025-11-13
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