Description

You will lead clinical research initiatives and manage global operational aspects of clinical trials, ensuring efficient execution across therapeutic and geographic areas. This role combines scientific expertise with operations management to meet regulatory standards and company objectives.

Requirements

• Bachelor’s Degree in life sciences, pharmacology, or a related field
• Minimum of 8 years of direct experience in operational management of multi-phase (I-IV) clinical research within pharmaceutical or biotechnology industry
• Demonstrated working knowledge of all relevant regulations including Good Clinical Practice (GCP), FDA regulations, and ICH guidelines
• Documented experience with or direct involvement in IND and CTA filing processes
• Willingness and ability to travel up to 20% per month
• Legal authorization to work in the United States

Responsibilities

• Support design, implementation, and oversight of clinical trials from concept through completion
• Manage Contract Research Organizations (CROs) to ensure clinical operations align with study goals, budget, and timelines
• Oversee junior staff assigned to projects
• Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations
• Ensure robust patient recruitment and retention strategies
• Drive program level consistency in data collection and compliance
• Analyze, troubleshoot, and interpret clinical data, prepare reports, and communicate findings
• Ensure accurate data collection, documentation, and record-keeping
• Identify potential risks and implement contingency plans
• Keep abreast of industry developments, regulatory changes, and advancements in clinical research methodologies
• Develop and maintain effective working relationships with cross-functional teams, external partners, and study sites