Clinical Trial Manager Associate, Clinical Operations

Jobgether SRL; United States; Remote; USD 108,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision, life and disa

Job summary

The Partner Company is seeking a Clinical Trial Manager Associate, Clinical Operations in the United States to support oncology studies. You will manage clinical study vendors, ensure timelines, budgets, and quality, and collaborate with CROs and internal teams to drive study execution.

Responsibilities include vendor meetings, risk mitigation, site initiation support, TMF accuracy, budget tracking, and regulatory compliance with GCP/ICH/FDA. Travel up to 10% is expected.

Qualifications

• 2–3 years of clinical operations experience in biotech/pharma/CRO.
• Bachelor’s degree in a scientific, healthcare, or related discipline preferred.
• Experience managing or supporting clinical study vendors; monitoring performance and issue escalation.
• Working knowledge of GCP, ICH, FDA and SOP requirements.
• Strong organizational skills and exceptional attention to detail with quality focus.
• Proactive communication style with clear updates to stakeholders.
• Ability to work independently within cross‑functional teams and adapt to change.
• Willingness to travel up to 10%.

Responsibilities

• Manage key clinical study vendors to meet timelines, budgets, quality, and regulations.
• Participate in vendor meetings, planning, risk mitigation, and performance reviews using KPIs.
• Support Study Lead in CRO activities and document reviews (protocols, ICFs, study plans).
• Participate in CRO and Study Execution Team meetings and support start-up planning.
• Support site management activities including feasibility, site initiation, and issue resolution.
• Track study documentation and maintain Trial Master File accuracy and completeness.
• Monitor vendor progress, identify risks, and elevate issues to stakeholders.
• Assist with study vendor budgets, contracts, and invoice management.
• Summarize vendor performance and study status for the Study Lead and risk assessment.
• Collaborate across clinical operations and other teams to maintain quality and timelines.
• Utilize AI-enabled tools to improve productivity and operational efficiency.
• Travel internationally or domestically up to 10% as required.

Skills

Vendor management

Regulatory/compliance

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in scientific/healthcare discipline

Tools

Microsoft Project

Smartsheet

Job description

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.

Accountabilities

• 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 elevate 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%.

Requirements

• 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.

Benefits

• 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.