Associate Director, Data Management (Remote - US)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Data Management in the United States.

This role offers a strategic leadership opportunity for an experienced data management professional to oversee end-to-end clinical data operations across multiple studies. The Associate Director will lead the planning, execution, and quality control of clinical data management activities, collaborating closely with cross-functional study teams including biostatistics, programming, and vendors. This position requires expertise in electronic data capture systems, clinical database design, and regulatory compliance standards, while ensuring accurate, efficient, and timely delivery of high-quality data. The successful candidate will have the ability to guide and mentor team members, influence process improvements, and provide actionable insights to support clinical development programs. Strong organizational, analytical, and communication skills are essential to thrive in this fast-paced and highly collaborative environment.

Accountabilities

• Lead and oversee data management activities for clinical studies, ensuring accurate, complete, and compliant data capture and reporting.
• Manage relationships with CROs, vendors, and internal teams to monitor progress and performance of assigned studies.
• Review study protocols, eCRF designs, and related documentation to ensure proper data collection standards.
• Develop and implement data edit checks, listings, database design, and testing in accordance with company standards.
• Coordinate data management plans, data transfers, reconciliations, and database lock/freeze activities.
• Provide training on EDC systems and data management guidelines for internal and external team members.
• Ensure regulatory compliance, adherence to Good Clinical Data Management Practices (GCDMP), and maintenance of data management files/eTMF.
• Participate in study meetings, provide updates and metrics, and support process improvements across the data management function.

• Bachelor’s degree or higher in a life sciences-related field or equivalent experience.
• 9+ years of experience in clinical data management within biotech/pharmaceutical industries or service providers, including 3+ years in a lead data management role.
• Hands-on experience in all phases of clinical trials, including database design, validation, deployment, and closeout.
• Strong knowledge of CDISC data standards, ICH GCP guidelines, and global clinical data management best practices.
• Proficiency with clinical data management systems (e.g., Medidata Rave) and external data sources (IRT, labs, safety, PROs, reading centers).
• Demonstrated ability to manage vendors and assess performance effectively.
• Excellent organizational, project management, analytical, and strategic thinking skills.
• Strong written and verbal communication skills and ability to collaborate in a high-paced, small company environment.
• Attention to detail, multitasking ability, and adaptability to shifting priorities and deadlines.
• Experience in retina diseases and/or gene therapy programs is a plus.
• Willingness to travel up to 5% as needed.