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United States
Onsite
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager Associate, Clinical Operations based in United States.
This role supports the successful execution of clinical studies within a fast-paced, innovative oncology environment.
You will take ownership of key clinical vendor relationships and help ensure study activities are delivered on time, within budget, and to high-quality standards.
The position combines vendor management, study operations, documentation, risk management, and cross-functional collaboration.
You will work closely with Study Leads, CROs, clinical vendors, and internal teams to support efficient study and country start-up activities.
Your contributions will help maintain regulatory compliance with GCP, ICH, FDA requirements, and applicable SOPs.
The role offers meaningful exposure to clinical development programs and the opportunity to contribute to therapies designed to improve outcomes for patients with cancer.
With a collaborative and entrepreneurial environment, this position is well suited to an organized clinical operations professional who is proactive, detail-oriented, and eager to make an impact.
Manage key clinical study vendors, including central laboratories, RTSM/IRT, imaging, dosimetry, and other specialized providers, ensuring deliverables meet timelines, budgets, quality standards, and applicable regulations.
Participate actively in vendor meetings, operational planning, risk mitigation activities, and performance reviews, using key performance indicators and vendor metrics to monitor execution.
Support the Study Lead in managing CRO activities, including reviewing protocols, informed consent forms, study plans, and other essential documents.
Participate in CRO and Study Execution Team meetings and contribute to operational strategy, including study and country start-up planning.
Support site management activities such as feasibility assessments, site selection, site initiation, and resolution of operational issues.
Track and maintain essential study documentation and support Trial Master File completeness, accuracy, and quality.
Monitor vendor progress, identify emerging risks or delays, and proactively escalate issues to appropriate internal stakeholders for resolution.
Support study vendor budgets, contract-related activities, and invoice management while monitoring financial performance.
Summarize vendor performance and study status information for the Study Lead and contribute to risk identification and mitigation.
Collaborate effectively across clinical operations and other functional teams to maintain study quality, timelines, and compliance.
Use appropriate technology and AI-enabled tools to improve individual productivity, work quality, and operational efficiency.
Travel internationally or domestically as required, with travel expected to be up to 10%.
2–3 years of clinical operations experience within the biotechnology, pharmaceutical, or CRO industry.
Bachelor’s degree in a scientific, healthcare, or related discipline preferred.
Experience managing or supporting clinical study vendors and familiarity with vendor deliverables, performance monitoring, and issue escalation.
Working knowledge of clinical trial processes and applicable GCP, ICH, FDA, and SOP requirements.
Strong organizational skills with exceptional attention to detail and a consistent focus on quality.
Proactive communication style, with the ability to provide clear and timely updates to internal and external stakeholders.
Ability to work independently while contributing effectively within cross-functional teams.
Comfortable operating in a dynamic environment where priorities can change and flexibility is essential.
Strong problem-solving and action-oriented mindset, with the ability to identify issues and drive them toward resolution.
Experience with Microsoft Project and Smartsheet is desirable.
Willingness and ability to travel up to 10% as business needs require.
Base salary range of $107,508–$130,274 USD annually for full-time employees.
Potential eligibility for discretionary incentive compensation and stock opportunities.
Comprehensive benefits covering medical, dental, vision, life, and disability insurance.
Wellbeing support and retirement and financial protection programs.
Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
Paid company holidays, with additional vacation and optional holiday benefits depending on employment classification.
Additional eligible time-off programs, including paid sick leave and up to two paid volunteer days annually.
Summer hours flexibility and leave programs supporting medical, personal, parental, caregiver, bereavement, and military needs.
Annual global shutdown period between Christmas Day and New Year’s Day for eligible employees.
A remote work environment with opportunities to contribute to innovative oncology clinical development programs.
Supportive and collaborative workplace focused on professional growth, meaningful scientific work, and patient impact.
