Operational Design Lead (US-Remote)

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Requirements:

• Doctorate degree and 2 years of clinical research experience OR
• Master’s degree and 4 years of clinical research experience OR
• Bachelor’s degree and 6 years of clinical research experience OR
• Associate’s degree and 10 years of clinical research experience OR
• High school diploma/GED and 12 years of clinical research experience.
• 9+ years in life sciences or medically related field, with 6+ years in biopharmaceutical clinical research.
• Strong background in clinical operations or study feasibility.
• Understanding of trade-offs in optimal study design, operational efficiency, and costs.
• Experience in leading cross-functional teams.
• Project management skills to facilitate discussions and decision-making.

Responsibilities:

• Serves as a Project Leader for study design and protocol development for late-stage studies.
• Partners with stakeholders to assess operational impacts, study startup paths, and recruitment implications.
• Connects teams to resources for data-driven decisions.
• Facilitates decision-making in line with clinical development strategy.
• Identifies disconfirming information to ensure efficient study design.
• Clarifies responsibilities and obtains necessary cross-functional input.
• Establishes development timelines aligned with regulatory requirements.
• Advises on risk assessment and mitigates potential study delays.
• Contributes to process improvements in study design and operational execution.
• Keeps updated with industry best practices and trends.