Clinical Research

• Serves as the clinical trial lead responsible for planning, conduct and oversight of clinical studies
• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related clinical documents
• Identify and develop training needs for CRAs and third-party vendors
• Generate potential site list from key stakeholders
• Identify potential risks to the enrollment targets
• Develop timely and effective communication and good working relationships with investigators and study team
• Lead internal clinical team meetings and sets expectations
• Address all CRA and site questions
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies
• Generate and utilize metric reporting
• Responsible for eTMF implementation and management
• Collaborate on corrective actions and accountability
• Assist sites and staff with GCP audits
• Manage processes for investigational product
• Support business development and marketing activities
• Negotiate site budget and contracts
• Review site visit reports and monitoring plans

Clinical Trial Manager, Senior

Director of Strategy – Business Operations, Healthcare, Clinical Research

Channel Manager, Clinical Research Organizations

Principal Biostatistician – RWE Specialist

Clinical Trial Manager, Phase 3

Clinical Scientist