Rare Disease Translational Center (RDTC)
The Associate Study Director supports the planning, execution, and oversight of preclinical and translational research studies within the Rare Disease Translational Center.
Working under the guidance of Study Directors and Senior Study Directors, this role coordinates study activities across cross-functional teams, tracks project milestones, supports regulatory compliance, and contributes scientific expertise to ensure the successful delivery of high-quality research outcomes.
The Associate Study Director serves as a key operational and scientific partner, helping to drive study execution while developing increasing independence in study leadership and project management.
Key Responsibilities and Essential Functions
• Assist in the development of study protocols, including study design, methodology, and timelines.
• Ensuring adherence to protocols, timelines, and regulatory requirements.
• Conduct data analysis and interpretation, utilizing statistical methods and software tools as needed.
• Maintain accurate and detailed records of study procedures, results, and observations in compliance with regulatory standards.
• Implement quality control measures to ensure the accuracy, reliability, and integrity of study data.
• Collaborate with cross-functional teams, including scientists, technicians, and regulatory affairs personnel, to facilitate smooth communication and workflow.
• Ensure studies are conducted in accordance with relevant regulations, guidelines, and industry standards.
• Identify opportunities for process optimization and efficiency enhancements within the study management process.
• Other duties as assigned.
Knowledge, Skills, and Abilities
• Strong organizational skills with the ability to effectively prioritize tasks and manage multiple projects simultaneously.
• Proficiency in data analysis and interpretation, with a solid understanding of statistical methods and software tools (e.g., SAS, R, SPSS).
• Excellent verbal and written communication skills, with the ability to convey complex scientific concepts to diverse audiences.
• Demonstrated ability to work collaboratively in a team environment, fostering a positive and productive work culture.
• Meticulous attention to detail and accuracy in documentation and record-keeping.
• Ensure studies are conducted with relevant regulatory requirements.
• Strong problem-solving skills with the ability to identify issues and implement effective solutions in a timely manner.
• Flexibility and adaptability to changing priorities and deadlines in a fast-paced, dynamic work environment.
Educational Requirements
Bachelor's Degree required, PhD preferred
Experience Requirements
5 years
Pay Range: $80,167-$116,242, pay is determined by experience
