Senior Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the comprehensive implementation of clinical operations for Phase I through Phase III trials.

• Act as the main liaison for CROs, Service Providers, site investigators, study personnel, internal Uniphar functional areas, Product Development Team members, and partners.

• Direct the management of clinical trials from pre-study planning and protocol evaluation to the finalization of clinical study reports for regulatory submission.

• Ensure that trial execution adheres to ICH-GCP, FDA/EMA, and other regulatory authority guidelines, as well as SOPs, timelines, budgets, operational procedures, and quality standards.

• Oversee study activities, timelines, objectives, budgets, and compliance with GCP/ICH.

• Supervise CRO and vendor operations, contracts, budgets, and invoices.

• Facilitate internal study team meetings and coordinate study-related documents and operational manuals.

• Manage investigator recruitment and the execution of trials at investigative sites.

• Engage in monitoring visits, assess monitoring reports and correspondence, and ensure the quality of CRO services.

• Organize and lead Investigators' Meetings, Site Initiation Visits, CRA/Monitor training, and other training related to the study.

• Monitor data collection, resolve queries, oversee monitoring, and ensure adherence to protocols while managing protocol deviations.

• Escalate project challenges and risks to Senior Management and implement necessary solutions.

• Perform clinical data quality control and create corrective action plans.

• Provide ongoing study updates and status reports to Senior Management.

• Assist with knowledge management, SOP development, data monitoring committees, CRO audits, and vendor qualification processes.

• Collaborate with Project Management & Planning to predict budgets and contribute to integrated study timelines.

• Carry out assigned sub-projects and additional duties as directed by Senior Management.

⛳️ Requirements

• Bachelor's degree or equivalent (preferably in life sciences).

• Minimum of eight years of experience in clinical trial research management within a pharmaceutical, biotechnology, or CRO environment.

• At least two years of experience in project management.

• A minimum of four years of monitoring experience, with the ability to independently conduct all types of monitoring visits.

• Proven experience managing multiple or complex projects from Phase I to Phase III.

• Experience with global clinical trials and multiple-CRO partnerships is preferred.

• Skilled in managing CROs, Service Providers, and contractors.

• Previous experience in managing vendor contracts and budgets is preferred.

• Strong grasp of clinical research operations.

• Knowledge of FDA regulations, ICH/GCP guidelines, and their application and implementation.

• Ability to collaborate effectively with study teams, cross-functional team members, and external partners/Service Providers.

• Excellent operational and management skills with a keen attention to detail.

• Strong communication abilities.

• Proficient in Microsoft Outlook, Excel, Word, PowerPoint, and Project.

• Willingness to travel up to 20%, depending on assigned responsibilities.

🏝️ Benefits

• Bonus opportunities.

• Commitment to equal opportunity employment.

• Willingness to travel up to 20% based on assigned responsibilities.