Senior Manager / Associate Director, Clinical Data Management

The Senior Manager / Associate Director of Clinical Data Management (CDM) will lead and oversee clinical data management activities across Sironax clinical programs, ensuring the delivery of high-quality, compliant, and timely clinical trial data. This role serves as a hands-on leader and subject matter expert, partnering closely with Clinical Development, Biometrics, Medical, Regulatory, and external vendors (CROs) to support decision-making and regulatory submissions. The level (Senior Manager vs Associate Director) will be determined based on experience and scope of responsibility. Key Responsibilities: - Provide operational and strategic leadership for clinical data management activities across Phase I–III (and IV as applicable) studies. - Develop, review, and maintain Data Management Plans (DMPs), CRFs/eCRFs, edit checks, and data review strategies. - Oversee database build, UAT, data cleaning, medical coding, and database lock activities. - Ensure compliance with global regulatory requirements including ICH-GCP, 21 CFR Part 11, and GCDMP. - Manage and oversee CROs and data vendors, including scope definition, oversight, performance tracking, and issue resolution. - Apply risk-based data management and quality oversight methodologies to proactively identify and mitigate data risks. - Serve as the data management representative on cross-functional study teams and governance forums. - Support inspection readiness and participate in audits and regulatory interactions as needed. - Contribute to the development and continuous improvement of CDM SOPs, standards, and best practices. - Mentor and guide junior data management staff and provide functional leadership as the organization grows.