Sr. Clinical Trial Manager - Oncology, Cell & Gene Therapy

Senior Clinical Trial Manager - Oncology, Cell & Gene Therapy

Location: United States – Remote

Harvest Integrated Research Organization (HiRO)

About HiRO

Harvest Integrated Research Organization (HiRO) is an innovative, globally oriented boutique Contract Research Organization (CRO) dedicated to advancing clinical research across international markets.

We collaborate closely with biotechnology and pharmaceutical companies to bridge the gap between scientific discovery and commercialization through efficient, high-quality clinical development solutions.

Our team members are curious, collaborative, and determined to transform challenges into opportunities. We are committed to delivering innovative, capital-efficient clinical research solutions that ultimately benefit patients worldwide.

Job Summary

HiRO is seeking an experienced Senior Clinical Trial Manager (Sr. CTM) to join our growing global Clinical Operations team.

The ideal candidate will bring a strong background in oncology and hematology clinical research, with particular interest in candidates experienced in CAR-T, Cell and Gene Therapy (CGT), and other complex or emerging therapeutic modalities.

This position requires a minimum of five years of Clinical Trial Management experience within a Contract Research Organization (CRO) or equivalent clinical trial leadership experience.

The Senior CTM will provide operational leadership, oversight, and strategic direction for clinical trials while ensuring quality, regulatory compliance, timeline adherence, and financial performance.

The successful candidate will demonstrate the ability to manage complex clinical programs, lead cross-functional teams, and adapt their expertise to evolving therapeutic areas.

Experience in radiopharmaceutical clinical trials is desirable but not required. Candidates with strong experience managing complex oncology, CAR-T, or cell and gene therapy studies who demonstrate the ability to learn new therapeutic modalities are encouraged to apply.

Key Responsibilities

Clinical Trial Leadership & Oversight

• Provide operational leadership and oversight of clinical monitoring activities across assigned clinical trials.
• Manage clinical monitoring teams, including workload distribution, site assignments, and performance expectations.
• Ensure clinical trial milestones, deliverables, timelines, and financial objectives are achieved.
• Develop, implement, and maintain Clinical Management Plans (CMPs), monitoring strategies, and risk mitigation plans.
• Oversee monitoring activities to ensure protocol compliance, data quality, patient safety, and inspection readiness.
• Identify operational challenges, implement corrective action plans, and escalate risks appropriately.

Cross-Functional Collaboration

• Collaborate with sponsors, investigators, clinical sites, and internal functional teams to ensure successful study execution.
• Work closely with Medical Monitoring, Safety, Regulatory Affairs, Quality Assurance, and other clinical development functions.
• Facilitate communication and alignment among geographically dispersed teams.
• Participate in investigator meetings, study launch meetings, and other client-facing activities.
• Support business development initiatives, including proposal development, bid defenses, and operational feasibility assessments.

Team Development & Operational Excellence

• Provide coaching, mentoring, and technical guidance to Clinical Trial Managers and Clinical Research Associates.
• Support the professional development of clinical operations team members.
• Promote consistent application of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Identify opportunities to improve clinical operations processes, efficiency, and quality.
• Contribute to the development and implementation of best practices across therapeutic areas and clinical programs.

Required Qualifications

• Bachelor's degree in a life sciences, healthcare, or related discipline; RN qualification; or an equivalent combination of education, training, and relevant experience.
• Minimum 5 years of Clinical Trial Management experience within a CRO environment, or equivalent clinical trial leadership experience.
• Approximately 7 or more years of overall clinical research experience preferred.
• Strong clinical trial management experience in oncology and/or hematology, including complex clinical trial protocols.
• Demonstrated experience leading clinical monitoring teams and managing clinical trial deliverables.
• Strong understanding of ICH-GCP guidelines, clinical research regulations, and quality management principles.
• Experience managing clinical trial budgets, timelines, resources, and operational risks.
• Demonstrated ability to work effectively across international teams, regions, and time zones.
• Strong leadership, communication, organizational, and problem-solving skills.
• Ability to adapt to emerging therapeutic areas and apply existing clinical operations expertise to new study requirements.
• Proficiency with clinical trial management systems and relevant Microsoft Office applications.
• Ability to travel as required.

Preferred Qualifications

• Clinical Trial Management experience involving CAR-T therapies, cell and gene therapies, or other advanced therapeutic modalities.
• Experience managing complex oncology or hematology studies requiring specialized treatment coordination, patient monitoring, or investigational product logistics.
• Familiarity with radiopharmaceutical clinical trials or other emerging oncology treatments.
• Experience managing global clinical trials.
• Previous experience mentoring or supervising CTMs and CRAs.
• Experience supporting clinical trial proposals, bid defenses, and sponsor presentations.

What We Offer

• A dynamic, innovative workplace that welcomes new ideas and approaches.
• Competitive compensation commensurate with experience.
• A collaborative global team committed to advancing clinical research.
• Opportunities for professional development and career advancement as our organization grows.
• Comprehensive benefits, including medical, dental, vision, short-term disability, long-term disability, 401(k), and more.

Equal Employment Opportunity

HiRO is committed to providing equal employment opportunities to all qualified applicants and employees.

We do not discriminate based on race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected by applicable law.

*This position is not open to agency solicitation.*