Job Description

The ideal candidate will be responsible for planning, coordinating, and implementing projects within the decided-upon budget, timeline, and scope. They will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members. 

Responsibilities

• Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
• Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
• Co-monitors as needed
• Develops and tracks study timelines, budget, and quality metrics
• Ensures appropriate clinical resources are available for the clinical project
• Ensures GCP and regulatory compliance is maintained
• Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
• Maintains professional expertise through familiarity with therapeutic area and clinical research literature
• Manages clinical projects from concept through clinical study report completion
• Oversees clinical research study conduct
• Manages, mentors, and develops direct reports
• Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources
• Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
• Participates in meetings with investigative sites, key opinion leaders and consultants as needed
• Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
• Aides in the training and development of all clinical staff members
• Performs other duties as assigned
• 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
• Reviews and approves invoices from study vendors, investigators, consultants, etc.
• 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:

• 5+ years project-lead or management experience
• Medical Degree/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
• Excellent organizational, leadership and problem-solving skills
• Excellent written and verbal communication skills
• Experience in leading cross-functional teams to meet goals and metrics
• Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• 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