About the role
We're seeking an energetic, detail-oriented, proactive, and hands-on Clinical Trial Manager who thrives in a fast-paced environment. In this role, you'll support the day-to-day clinical operations oversight for clinical trials as assigned. The ideal candidate should also be willing to roll up sleeves and handle tasks that might be delegated at larger companies. This position will report to the Director of Clinical Operations.
What you'll do
- 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
Qualifications
- 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
- Oncology experience strongly preferred
- Comfortable with ~20% travel
What We Offer
- 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.
Why Join Quetzal?
This role provides an exceptional opportunity to shape the future of innovative therapies at a nimble, growth-oriented biotech company. The position offers broad exposure to all aspects of clinical development, enabling significant strategic and operational impact across the product lifecycle.
DISCLAIMER: The list under Role Responsibilities is not exhaustive but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEO Statement: Quetzal is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation.