Clinical Project Manager

Summary

Join MCRA, a leading medical device advisory firm and CRO, as a Clinical Project Manager specializing in orthopedic and spine devices. You will play a critical role in managing clinical study projects, overseeing all clinical aspects of trial development and execution, and ensuring compliance with GCP guidelines and regulations. Lead and direct project teams, track study progress, develop project documents, and oversee monitoring activities. Approve reports, maintain the Trial Master File, oversee vendors, and provide training. Build and maintain positive relationships with clients, team members, and site personnel. Assist with professional development for clinical research associates. Maintain knowledge of current GCP, FDA, and other applicable regulations. This position requires a Bachelor's degree, 5+ years of clinical trial experience (including 2+ years of supervisory experience), and orthopedic/spine medical device experience.

Requirements

• Bachelor's degree in healthcare or a related discipline required
• 5+ years of experience in clinical trials with at least 2 years of supervisory/management experience in a clinical research environment
• Orthopedic and Spine medical device experience required
• Knowledge of clinical project management, GCPs, and clinical monitoring procedures
• Demonstrated ability to manage multiple clinical studies simultaneously
• Understanding of therapeutic area for assigned clinical projects
• Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring
• Must be a talented consensus builder and team player with the ability to engage and influence a multi-functional team
• Ability to manage clients independently
• Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry
• Advanced Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
• Excellent organization and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
• Excellent oral and written communication skills
• Travel: 10%
• Home office or DC-office based

Responsibilities

• Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures
• Lead and direct project team to ensure deliverables meet project timelines
• Track and report on progress of study including site activation, patient enrollment, and monitoring visits
• Develop Clinical Monitoring Plan and other project documents as assigned
• Oversee all clinical monitoring activities for clinical studies, including remote monitoring and remote site management
• Approve reports and study communications generated by the project team for distribution to sponsors and investigators
• Ensure Trial Master File is accurate and complete throughout the lifecycle of the project
• Oversee study vendors, when applicable
• Provide ongoing study training to the clinical project team
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
• Assist with professional development for Clinical Research Associates and Clinical Associates
• Maintain knowledge of current GCP, FDA, and other applicable regulations
• Ensure work meets client and company standards
• Assisting with hiring and training of qualified candidates
• Oversee the day-to-day workflow of assigned clinical staff
• Conduct performance evaluations that are timely and constructive