Clinical Project Manager

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.  Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.   We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.  
ABOUT THE JOB   The Clinical Project Manager (Clinical PM) plays a key role in the successful conduct of a clinical trial from inception through implementation and completion. The Clinical PM provides overall coordination and strategic management of a clinical trial, in conjunction with the clinical team and other functional groups. The Clinical Project Manager serves as the primary contact with the sponsor, clinical team, and other functional groups, while effectively delegating, and overseeing team members.   The Clinical Project Manager ensures that all study team members are appropriately trained on the study and maintain compliance with GCP, the protocol, other associated documents, scope of work, and other clinical objectives. The Clinical PM serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. The Clinical Project Manager also supports team member mentorship, as needed.  

HERE IS WHAT YOU WILL DO:

• Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection
• Facilitate and foster positive, productive, and timely communication between sponsor, study team, and other functional groups
• Manage and motivate study team while serving as a mentor; mentorship may include identifying skills of the clinical team members and assisting with further professional development
• Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department
• Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals
• Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
• Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans