Senior Manager, Data Management

Accountabilities

You will oversee clinical data management strategy and execution for assigned studies, ensuring that all deliverables meet quality standards, regulatory expectations, and established timelines. Your responsibilities will include:

• Serve as the lead Clinical Data Manager and primary Data Management contact for assigned studies, overseeing study-level activities, external vendors, timelines, and key milestones.

• Lead core data management processes, including EDC database development, eCRF design, edit check specifications, user acceptance testing, Data Management Plans, database changes, data cleaning, external data reconciliation, and database lock activities.

• Oversee Data Management deliverables across assigned programs and provide expert guidance on the setup, configuration review, and user acceptance testing of Randomization and Trial Supply Management (RTSM) systems.

• Ensure RTSM configuration aligns with protocol requirements for randomization, stratification, treatment assignment, dosing, and clinical supply management.

• Translate clinical protocol requirements into fit-for-purpose electronic Case Report Forms (eCRFs), data collection processes, and study-specific data review tools.

• Mentor and train junior and mid-level Data Management team members and cross-functional partners on systems, study procedures, standards, and best practices.

• Support line-management responsibilities when assigned and contribute to team development and knowledge sharing.

• Lead initiatives to improve and standardize Data Management processes in collaboration with functional leadership.

• Represent the Data Management function in cross-functional and external vendor meetings, ensuring alignment on priorities, expectations, and deliverables.

• Maintain data quality throughout the study lifecycle by overseeing data reviews, resolving issues, and ensuring database lock readiness.

• Lead the development and user acceptance testing of CRFs and edit check specifications throughout the study lifecycle.

• Manage external data transfers, reconciliations, and system integrations to ensure data integrity and completeness.

• Draft, review, and maintain Data Management Plans, data entry guidelines, data management reports, and other study-related documentation.

• Develop and maintain safety and customized data listings, metrics, and reports to support medical reviews, clinical reviews, risk-based monitoring, and study oversight.

• Ensure all Data Management Trial Master File (TMF) documentation is properly archived and maintained for inspection readiness.

Requirements:

The ideal candidate is an experienced clinical data management professional with a strong background in Phase II and Phase III clinical studies, advanced knowledge of clinical data systems, and the leadership skills needed to manage complex study requirements independently. The following qualifications are expected:

• Bachelor's degree required; a scientific or healthcare-related degree is preferred.

• At least 7 years of clinical data management experience in the biotechnology, pharmaceutical, or clinical research organization industry.

• At least 3 years of experience serving as the lead Data Manager for Phase II and Phase III clinical studies.

• Demonstrated experience with Electronic Data Capture (EDC) system development and mid-study change implementation, including eCRF design and edit check specification development. EDC Designer certifications are an advantage.

• Strong hands-on experience with the setup, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems for clinical trials.

• Strong project management capabilities, including timeline development, prioritization, deliverable monitoring, risk identification, and timely issue resolution.

• In-depth knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11 requirements, and industry standards applicable to clinical data management.

• Familiarity with CDISC standards, including CDASH and SDTM concepts, and experience applying data standards to clinical study design and execution.

• Experience with eCOA/ePRO, medical coding, safety systems, data warehouses, and data visualization tools is preferred.

• Excellent analytical, problem-solving, organizational, and decision-making skills, with strong attention to detail and a consistent focus on data quality.

• Ability to manage multiple studies and competing priorities in a fast-paced environment while maintaining accountability for timelines, quality, and regulatory compliance.

• Excellent written and verbal communication skills, with the ability to explain technical concepts to different audiences.

• Collaborative, solutions-oriented leadership style and a proactive approach to continuous improvement, innovation, and team development.

• Ability to work on-site in New York City at least three days per week, specifically Monday, Tuesday, and Thursday. Fully remote arrangements are not available.

Benefits:

• Anticipated annual salary range of $145,000–$160,000, depending on experience, qualifications, internal equity, and location.

• Annual bonus eligibility.

• Significant equity opportunities.

• Competitive and comprehensive employee benefits package.

• Potential flexibility in the final job title and scope of responsibilities based on the candidate's experience and qualifications.

• Opportunity to contribute to clinical research programs addressing significant neurological and psychiatric conditions.