Clinical Trial Manager

Description

The Clinical Trial Manager (CTM) will be responsible for leading clinical trial operational activities for various assets within Prelude Therapeutics’ pipeline while having the ability to multi-task on other company initiatives and activities. The individual will ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs, and business guidelines.

Responsibilities and Duties:

• •Manage and oversee one or more clinical trials including all day-to-day operational aspects and internal and external study teams
• •Leads the assigned cross functional study team fostering a collaborative team culture while ensuring clinical trial goals and timelines are met with quality, in compliance of SOPs and regulatory guidelines. Identifies and/or anticipates risks and plans accordingly for mitigation and escalates issues to management, as necessary.
• •Partner, oversee, and monitor CRO performance for all contracted services
• •Establishes and maintains study timelines and tracks clinical trial progress.
• •Provide strategic clinical trial input related to study logistics, management and oversight of enrollment (including forecasting), clinical supply and drug supply, data review and data cleaning and Trial Master Files.
• •Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, multiple clinical trial plans, EDC/CRFs, pharmacy manual, oversight manuals, clinical study reports, patient narratives and Clinical Trial Agreements (Clinical and Legal review).
• •Management of CRO/Vendors and risk mitigation strategic input to ensure goals and deliverables are met with quality per contracted scope of work and in compliance with ICH/GCP and regulatory guidelines. This includes monitoring oversight including authoring of oversight plans, review of monitoring visit reports and conducting sponsor oversight visits (as needed).
• •Contributes to clinical / regulatory submissions (FDA, EMA, Canadian and other countries), IRB / EC submissions, review, and approval of regulatory packages (as needed), assisting with in house and site inspection readiness planning and training.
• •Assist in the review of clinical trial key data points to include key efficacy and drug safety data.
• •Supports the development, management and tracking of trial budget(s) working closely with the appropriate partners.
• •Lead vendor selection/management process including RFP preparation, bid defense, vendor contracting and invoice reconciliation.
• •Provide direct management of one or more direct reports, including performance management and career development
• •Assist with clinical operations process development.
• •Some travel will be required (10-20% depending on project needs).

Requirements

• •Bachelor’s degree is required
• •3 -5 years of direct clinical study management experience including all phases of a clinical trial from start-up through closeout in clinical operations is required.
• •7-10 years of clinical operations management experience in a pharmaceutical, clinical research organization (CRO) or investigator site setting; including accountability for clinical trial programs and oversight of personnel and vendors.
• •Experience managing either oncology or complex clinical trials is required. Early development phase oncology clinical trial management experience preferred.
• •Global clinical trial experience and the ability to support more than one clinical trial is required.
• •Good working knowledge of ICH/GCP
• •Experience with various clinical trial systems (EDC, CTMS, TMFs), trial master file organization, regulatory documents, inspection preparation/readiness (site and sponsor) required
• •Previous site monitoring experience preferred.
• •Experience overseeing CROs/Vendors is required.
• •Experience in vendor/site contract review is required.
• •Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).
• •Ability to manage a remote team is required.
• •As key leadership competencies, this position builds strong relationships with peers and cross- functionally with partners outside of team to enable higher performance.
• •Excellent communication skills, experience mentoring clinical study staff and presenting to senior management is required.
• •Self-motivated individual comfortable with shifting priorities and regular change.