Clinical Project Manager

Responsibilities

• Leads clinical projects, including the management of cross-functional project teams and vendors or work alongside the global Project Lead on larger, complex or global studies, when more than 1 PM is required to manage a trial
• Establishes and maintains project timelines; organizes, leads project team meetings and manages follow up
• Develops and maintains project management plans and reviews functional area plans and other project documents to ensure consistency across documents and with the scope of work
• Establishes and manages project vendor and site budgets, forecasts budgets and activities, tracks out-of-scope activities, and ensures budget adherence by internal and external team members; oversees vendor contracts and site budgets/contract amendments; manages the Investigator Grant Payment (IGP) process, ensuring sufficient contracted funds are in place to support projected enrollment and site-related costs throughout the study
• Negotiates client requests that result in changes in scope or opportunities to expand business or scope
• Manages cross-functional project resources, ensuring that project tasks are correctly assigned to staff and vendors; identifies when additional resources are required; provides timely and accurate performance feedback to team members and escalates to management, as appropriate
• Serves as the primary project and client liaison, providing timely, clear, and appropriate levels of communication and customer service
• Builds and maintains positive client and stakeholder relationships, understanding project level requirements and level of satisfaction with progress and performance, and recognizing additional opportunities to expand business or scope
• Identifies, evaluates, and manages project risks and study trends throughout the trial conduct with internal and external stakeholders and escalates, when appropriate
• Coordinates inspection readiness efforts by proactively managing project documentation, identifying compliance gaps and participates in audits and inspections
• Reviews project operational metrics, identifies risks and issues across the project, and works with project team to address concerns
• Provides status updates to leadership, including the development of slides and presentations at project oversight meetings; also provides status updates to clients
• Builds relationships with global, cross-functional project team members
• Trains and mentors Project Management employees including Project Managers, APMs, and Project Associates
• May support the Contracts and Proposals and Business Development teams with RFIs and RFPs, including participating in bid defenses

Qualifications

• Bachelor’s Degree, preferably in life sciences or public health along with at least 3 years working in clinical project management ideally within a CRO environment
• Ideally you will have experience in neurology, analgesia, respiratory, immunology or dermatology
• Knowledge of clinical trial processes and client expectations
• Ability to lead components of clinical projects, including study start up and close out, as well as establish and manage project budgets and develop project management plans; understanding of protocol development and/or review and familiarity with drug development process, ICH-GCP guidelines, and federal regulations
• Ability to proactively identify issues with project and lead resolution within the team, with assistance; developing problem-solving skills, judgment and the ability to anticipate necessary action
• Makes data-driven decisions and resolves issues proactively
• Strong written, verbal, presentation and communication skills along with diplomatic negotiation skills
• Ability to lead, coordinate, and motivate teams and delegate and prioritize work of self and team members