Clinical Project Manager

Summary of Position:

Clinical Project Manager plays an important part in the clinical trial process.  The CPM position will perform a wide variety of activities to support the startup and completion of clinical research studies and may supervise other clinical operations personnel.

Essential Functions:

• Achieves study objectives by working with CROs to set project priorities and milestones and resolve project conflicts from concept through final CSR
• Co-monitors with CROs CRAs as needed
• In conjunction with CRO, develops and tracks study timelines and quality metrics
• Ensures GCP and regulatory compliance is maintained through creation and management of CQP with Altimmune Quality group
• Assists in the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
• Assists in the logistics of IP, clinical lab samples and ancillary supply shipments
• Maintains professional expertise through familiarity with vaccine therapeutic area
• Manages, mentors, and develops direct reports
• Attends regularly scheduled cross-functional study team meetings with internal and external resources, CROs and site staff
• Participates in CRO and other vendor selection and management
• Participates in meetings with investigative sites, key opinion leaders and consultants as needed
• Proactively identifies and resolves issues, and participates in process improvement initiatives as required
• Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
• Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
• Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks

Job Requirements (Essential knowledge, skills and attributes):

• 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
• Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
• CRA certification (ACRP or equivalent) is strongly preferred
• Excellent organizational, leadership and problem-solving skills
• Excellent written and verbal communication skills
• Experience in leading cross-functional teams to meet goals and metrics
• Know-how in managing Phase I, II, & III clinical studies
• Experience in writing clinical study protocols, informed consent forms, and other clinical documents
• Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
• Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
• Working knowledge of MS Project for development and update of clinical study timelines