Clinical Trial Manager

Prelude Therapeutics Incorporated • Wilmington, DE

1d

About The Position

The Clinical Trial Manager (CTM) leads clinical trial operational activities for assets in Prelude Therapeutics’ pipeline and may contribute to other company initiatives. The CTM ensures assigned operational deliverables are completed according to timelines, budgets, operational procedures, quality standards, SOPs, and business guidelines.

The role manages one or more clinical trials and their day-to-day operations, leads cross-functional study teams, and oversees internal and external partners, including CROs and vendors. It involves maintaining study timelines, tracking progress, managing risks, providing strategic input on trial logistics and enrollment, and contributing to study documents, regulatory submissions, inspection readiness, data review, and trial budgets. The CTM also leads vendor selection and management, directly manages one or more employees, and supports clinical operations process development. Travel of 10–20% may be required, depending on project needs.

Requirements

• Bachelor’s degree.
• 3–5 years of direct clinical study management experience, including clinical operations across all trial phases from start-up through closeout.
• 7–10 years of clinical operations management experience in a pharmaceutical, CRO, or investigator-site setting, including accountability for clinical trial programs and oversight of personnel and vendors.
• Experience managing oncology or complex clinical trials.
• Global clinical trial experience and the ability to support more than one clinical trial.
• Good working knowledge of ICH/GCP.
• Experience with clinical trial systems, including EDC, CTMS, and TMFs; Trial Master File organization; regulatory documents; and site and sponsor inspection preparation/readiness.
• Experience overseeing CROs and vendors.
• Experience in vendor/site contract review.
• Excellent computer skills, including Microsoft Office Suite, Project, Word, Excel, PowerPoint, and Outlook.
• Ability to manage a remote team.
• Ability to build strong relationships with peers and cross-functional partners outside the team to enable higher performance.
• Excellent communication skills, experience mentoring clinical study staff, and experience presenting to senior management.
• Self-motivated and comfortable with shifting priorities and regular change.

Nice To Haves

• Early-development-phase oncology clinical trial management experience.
• Previous site-monitoring experience.

Responsibilities

• Manage and oversee one or more clinical trials, including day-to-day operational activities and internal and external study teams.
• Lead assigned cross-functional study teams, foster collaboration, and ensure trial goals and timelines are met with quality and in compliance with SOPs and regulatory guidelines.
• Identify or anticipate risks, plan mitigations, and escalate issues to management as necessary.
• Partner with, oversee, and monitor CRO performance for contracted services.
• Establish and maintain study timelines and track clinical trial progress.
• Provide strategic input on study logistics, management, enrollment forecasting, clinical and drug supply, data review and cleaning, and Trial Master Files.
• Contribute to the development, review, and approval of study documents, including protocols, ICFs, clinical trial plans, EDC/CRFs, pharmacy manuals, oversight manuals, clinical study reports, patient narratives, and Clinical Trial Agreements.
• Provide strategic input on CRO/vendor management and risk mitigation to ensure quality deliverables within contracted scopes and in compliance with ICH/GCP and regulatory guidelines.
• Support monitoring oversight, including authoring oversight plans, reviewing monitoring visit reports, and conducting sponsor oversight visits as needed.
• Contribute to clinical and regulatory submissions, including FDA, EMA, Canadian, and other-country submissions; support IRB/EC submissions and review and approval of regulatory packages as needed.
• Assist with in-house and site inspection-readiness planning and training.
• Assist in reviewing key clinical trial data points, including efficacy and drug safety data.
• Support development, management, and tracking of trial budgets in collaboration with appropriate partners.
• Lead vendor selection and management, including RFP preparation, bid defense, vendor contracting, and invoice reconciliation.
• Directly manage one or more direct reports, including performance management and career development.
• Assist with clinical operations process development.
• Travel as required, estimated at 10–20% depending on project needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager