Clinical Research Project Manager

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

📋 Description

• Take primary responsibility for assigned clinical research projects while ensuring adherence to relevant regulations, guidelines, and corporate policies throughout study activities.

• Oversee and implement the overall project scope, budget, and timelines.

• Identify key success factors for project analysis, reporting, and tracking.

• Manage resources and timelines related to all study start-up and implementation tasks.

• Lead the creation of study-specific protocols, consent forms, and other necessary trial materials.

• Ensure the proper development of study documents, including but not limited to study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents essential for conducting assigned studies.

• Engage in the review of clinical data for analysis purposes.

• Ensure all project tasks align with client expectations and are completed according to the contract, trial protocol, and Standard Operating Procedures (SOPs).

• Act as a liaison between clients and the internal team to guarantee proactive communication of project-specific information and ongoing updates.

• Plan and manage all materials necessary for the effective execution of clinical projects, which includes the distribution of documents, forms, supplies, equipment, and investigational devices.

• Monitor compliance with project contracts and budgetary constraints.

• Collaborate with clinical, business development, and operations management to define goals and scope for clinical study projects.

• Ensure the operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections as required.

• Assist in the management and oversight of clinical study-related vendors.

• Review site monitoring reports to ensure compliance with SOPs and/or client contractual obligations.

• Enhance the reputation of the department and organization by engaging in departmental or corporate initiatives.

• Update professional knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks, and engaging in professional organizations.

• Attend off-site meetings and conferences as necessary.

⛳️ Requirements

• A Bachelor’s degree or equivalent education in life science/healthcare is required, along with 5 years of experience in clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

• Experience within a CRO is highly desirable.

• Preferred experience managing external vendors.

• Preferred experience leading operational project teams during the start-up, study conduct, data management, and report writing phases of clinical studies.

• Preferred experience in writing, reviewing, and editing protocols and clinical study reports, along with a working knowledge of the FDA submission process.

🏝️ Benefits

• 100% Remote