Early Phase Clinical Trials Manager

We are seeking an *Early Phase Clinical Trials Manager* to lead the planning, coordination, and execution of early phase oncology clinical trials. The ideal candidate will have strong experience in clinical research, project management, regulatory compliance, and operational leadership, with the ability to manage multiple studies while ensuring high-quality study conduct, participant safety, and compliance with sponsor and regulatory requirements.

Responsibilities

* Lead the planning, coordination, and execution of early phase oncology clinical trials from study start-up through study close-out.
* Oversee study timelines, resources, logistics, and operational activities to ensure protocols are conducted in accordance with sponsor expectations, regulatory requirements, ethical standards, and institutional policies.
* Coordinate study start-up activities, including site readiness, regulatory documentation, study activation, and operational planning.
* Oversee patient recruitment, screening, enrollment, and informed consent processes to ensure protocol compliance and enrollment objectives are achieved.
* Monitor study progress and proactively identify and resolve operational issues that may impact study timelines or quality.
* Collaborate closely with Principal Investigators, Sub-Investigators, research nurses, clinical research coordinators, sponsors, CROs, study monitors, and other external partners to ensure successful study execution.
* Support participant safety monitoring by ensuring timely reporting and documentation of adverse events and protocol deviations, as applicable.
* Oversee the collection, review, and quality of clinical trial data while ensuring accurate and timely documentation in accordance with study protocols.
* Maintain complete, organized, and audit-ready regulatory, source, and study documentation.
* Coordinate sponsor monitoring visits, site qualification visits, audits, inspections, and regulatory reviews.
* Oversee study supplies, investigational product accountability, and other site logistics necessary to support trial operations.
* Prepare study reports, operational updates, and trial documentation for investigators, sponsors, and leadership.
* Promote continuous improvement initiatives that enhance clinical operations, study efficiency, regulatory compliance, and the overall participant experience.
* Provide leadership, guidance, and operational support to clinical research staff while fostering a collaborative and patient-centered research environment.

Qualifications

* Bachelor's degree in Nursing (RN) or Medical Laboratory Technology (Lab Tech) required. Candidates holding a Medical Doctor (MD) degree or currently pursuing an MD are also encouraged to apply.
* Experience in clinical research, preferably in oncology and/or early phase clinical trials, is highly desirable.
* Strong project management skills with the ability to coordinate multiple studies, timelines, and operational priorities.
* Experience coordinating study start-up activities, patient recruitment, informed consent, and clinical trial operations.
* Knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other applicable regulatory requirements.
* Experience preparing for sponsor visits, audits, inspections, and regulatory reviews.
* Familiarity with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and other clinical research technologies.
* Strong organizational, leadership, communication, and problem-solving skills.
* Ability to collaborate effectively with investigators, research nurses, clinical research coordinators, sponsors, CROs, and multidisciplinary teams.
* Bilingual (English and Spanish).

*We are an equal opportunity employer.*

Job Type: Full-time

Benefits:
* Health insurance
* Life insurance
* Paid time off



Experience:
* Clinical research: 1 year (Required)

Language:
* English (Required)

Work Location: In person