ProPharma

Clinical Operations

• Oversight and conduct of clinical research trials ensuring compliance with applicable regulations
• Ensure quality of clinical data meets requirements for Regulatory Authority approval
• Strategic and tactical operational planning and execution of all phases of clinical programs
• Partner with internal functions to develop clinical study plans, including timelines and budgets
• Prepare or facilitate preparation of essential study documentation (protocols, CRFs, informed consent forms, feasibility assessments)
• Lead and actively participate in cross-functional team meetings
• Support site activities: site identification, investigator meetings, site training, research agreements, and study budget negotiations
• Oversee or conduct study monitoring: develop monitoring plans, manage resources, perform initiation/interim/closeout visits and activities
• Perform or oversee study closeout procedures, product disposition, and prepare sites for audits
• Develop and maintain tracking systems for study management

Clinical Project Manager