Job Title: Clinical Operations Project Manager

Work Location: Remote

Summary:

Seeking a highly organized and proactive Clinical Operations Project Manager to oversee clinical studies from initiation to close-out. This role involves coordinating timelines, documentation, and communication across multiple stakeholders, while supporting the implementation of innovative mobile and cloud-based data capture technology. The ideal candidate excels in fast-paced environments, demonstrates strong collaboration and communication skills, and is passionate about advancing clinical research through digital solutions.

Responsibilities:

• Guide clinical studies through all phases, ensuring effective coordination among clients, sites, and internal teams.
• Manage project documentation, timelines, and support audit preparation and archiving activities.
• Conduct training sessions for site staff and users, including application demonstrations and device setup instructions.
• Maintain and update project data in databases, gathering information from internal team members as needed.
• Prepare and distribute project-related correspondence, such as meeting agendas, minutes, and presentations.
• Serve as the primary contact for site and CRA support, overseeing document collection, review, and study communications.
• Coordinate translation of project documents and act as liaison with translation vendors.
• Support meeting planning and execution, generate reports, and provide additional project support as directed.

Qualifications:

• Degree in a related field of study.
• At least two years of relevant industry experience or equivalent.
• Working knowledge of GCPs, ICH guidelines, FDA, and applicable healthcare regulations preferred.
• Proficiency in MS Office programs.
• Strong verbal and written communication skills.

Published Category: Clinical Operations & Development