CRO-Clinical Trials Manager

Evolution Research Group• US,

About The Position

The Clinical Trials Manager (CTM) manages the planning, implementation, and tracking of clinical monitoring, ensuring timely and high-quality delivery of project-specific on-site and remote monitoring services. The role supports monitoring team training compliance, tracks critical study tasks, and provides strategic and tactical enrollment planning and support. The CTM develops and monitors resource allocation plans to ensure compliance with project requirements and serves as a proactive member of the core project team, working closely with the Project Manager on clinical operations issues and deliverables. The CTM oversees clinical monitoring aspects of assigned studies, including site start-up, site management, monitoring, monitoring-related documentation, and quality control review of relevant Trial Master File documents. The role also develops study plans, monitoring strategies, tools, and templates; supports enrollment; tracks monitoring reports and follow-up letters; and identifies and escalates risks and issues. The position may supervise assigned CRAs and requires travel up to 20%.

Requirements

At least 6 years of clinical research experience.
At least 1 year of experience as a CTM or Lead CRA.
Ability to mentor and train CRAs positively and effectively.
In-depth knowledge of clinical trials and the critical elements for successful clinical trials.
Ability to manage project issues, understand contributing factors, identify and address problems, and propose, implement, and evaluate appropriate resolutions.
Proven organizational abilities and excellent written and oral communication skills.
Ability to facilitate teamwork with a positive attitude.
Strong organizing, coordinating, teaching, and facilitation skills, including the ability to assess training needs and objectives.
Experience overseeing and coordinating the work of others.
Ability to handle multiple tasks simultaneously and work effectively and efficiently.
Ability to exercise judgment and determine appropriate action for problems of varying complexity.
Ability to manage multiple deadlines and maintain a can-do attitude.

Nice To Haves

A degree in life sciences or a nursing qualification is preferred, but not required.

Responsibilities

Manage key site and monitoring study metrics and report progress on monitoring tasks and benchmarks.
Help develop study-specific plans and documents, including Monitoring Plans, Pharmacy Manuals, communication plans, monitoring report and follow-up letter templates, SIV slides, and CRA training materials.
Review and contribute to CRF guidelines and edit checks, protocols, informed consent forms, and other clinical research documents as assigned.
Oversee clinical monitoring for assigned studies, including site start-up, clinical site management, monitoring, filing monitoring-related documents in the Trial Master File, and participating in QC review of relevant TMF documents.
Provide enrollment tracking and support, and monitor site compliance with eDiaries, data entry, and query resolution.
Ensure the timelines and quality of clinical monitoring team deliverables; identify risks and issues and escalate them to the Project Manager and CRA Manager.
Ensure CRA compliance with the Monitoring Plan, conduct CRA training, and maintain training documentation and tracking.
Communicate monitoring and site management updates and issues during sponsor and internal team meetings.
Review and track monitoring visit reports and follow-up letters, ensuring timely submission and finalization.
Develop clinical monitoring strategies, study tools, and templates to support study timelines and quality deliverables.
Promote operational efficiency, teamwork, and high morale among CRAs.
Proactively prevent, identify, and track study process, monitoring, and site issues; work with CRAs to resolve action items.
Work with the Project Manager and CRA Manager on resourcing issues and escalate relevant CRA performance and site compliance issues.
Travel up to 20%.
May supervise assigned CRAs, including reviewing and approving timesheets and expenses.
Train and provide higher-level guidance in clinical monitoring and the development of monitoring tools.