Associate Study Director - RDTC

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.