Clinical Trial Manager

This is a fully remote position, open to applicants in United States, +4 more states.

📋 Description

• Oversee the daily operations of designated Phase I oncology clinical trials while ensuring adherence to GCP/ICH guidelines and regulatory standards.

• Lead or assist in cross-functional trial teams, which include vendors.

• Keep precise trial information updated in tracking systems and furnish stakeholders with progression reports.

• Identify, address, and escalate issues related to the trial.

• Develop or assist in creating core trial documents, trial plans, and system configurations.

• Prepare vendor specifications, project scopes, vendor selections, and manage vendor-team interactions.

• Lead or assist in feasibility assessments and the selection of countries and sites.

• Engage with investigators and site personnel to facilitate milestones and deliverables.

• Supervise timely clinical data cleaning, analysis, top-line results, data reviews, and the creation of statistical analysis plans.

• Lead or support training for investigators and site monitors and coordinate training for the trial team.

• Provide oversight and guidance for trial deliverables.

• Manage budgets for clinical trials, vendor contracts, timelines, and resources.

• Ensure the quality and completeness of the Trial Master File (TMF).

• Participate in activities to ensure readiness for inspections.

• Assess and implement patient-centered strategies for the assigned trials.

⛳️ Requirements

• A BA/BS degree with a minimum of 3 years of clinical trial experience, or an advanced degree (MS/PhD/PharmD) with at least 2 years of clinical trial management experience.

• In-depth knowledge of ICH/GCP guidelines and regulatory standards.

• Familiarity with protocols, clinical drug development processes, clinical trial design, trial planning and management, and monitoring.

• Strong project management capabilities and trial leadership skills.

• Exceptional interpersonal, written, and verbal communication skills, as well as administrative and computer proficiency.

• Proficient in English.

• Experience working with Phase I oncology.

• Global experience with a primary focus on independent vendor setup and management, oncology cohort management, and supporting dose escalation safety meetings.

• Willingness to work East Coast hours if based further West.

• Legal authorization to work in the country where the position is located.

• Approximately 25% travel is required.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Approximately 25% travel is required.