Axsome Therapeutics is seeking a Senior Manager, Clinical Data Management to lead and oversee end-to-end clinical data management activities for assigned clinical studies and programs. This role serves as the lead data manager and a subject matter expert in core Data Management processes, ensuring high-quality, timely, inspection-ready data in compliance with ICH-GCP, applicable regulatory requirements, industry standards, and company procedures. The Sr. Manager collaborates cross-functionally with key stakeholders, provides Data Management expertise and leadership throughout study execution, and is accountable for the quality and timely delivery of Data Management milestones from study start-up through database lock and archival. This role is expected to operate independently while providing mentorship to mid-level and junior team members. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week.
Responsibilities
Serve as the lead Clinical Data Manager and primary Data Management point of contact for assigned studies, providing oversight of study-level Data Management activities and vendors; Act as a subject matter expert in core Data Management processes, including EDC database development, eCRF design, edit check specification development, user acceptance testing, Data Management Plan development, mid-study EDC database changes, data cleaning, external data reconciliation management, and database lock activities; Oversee DM deliverables for assigned programs and provide expert leadership for the setup, configuration review, and user acceptance testing of Randomization and Trial Supply Management (RTSM); Lead the translation of protocol requirements into fit-for-purpose eCRFs, study-specific data collection processes, and data review tools; Mentor and train Data Management staff and cross-functional partners; may provide line-management support as assigned; Lead Data Management process improvement and standardization initiatives in collaboration with Data Management leadership; Represent the data management function in cross-functional team meetings and external vendor meetings; Maintain data quality throughout the study lifecycle, including oversight of data reviews, issue resolution, and database lock readiness activities; Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications; Serve as a subject matter expert for EDC systems; Manage external data transfers, reconciliations, and system integrations; Draft, review and maintain Data Management Plans, data entry guidelines, data management reports and other study related documents; Develop and maintain safety and other customized data listings, metrics and reports; Ensure archival of all Data Management Trial Master File (TMF) documents to ensure inspection readiness
Requirements
Bachelor's degree required; Minimum of 7 years of clinical data management experience in the biotechnology, pharmaceutical, or clinical research organization environment; At least 3 years serving as the lead data manager for Phase II and Phase III clinical studies; Demonstrated experience in Electronic Data Capture (EDC) systems development and mid-study change implementation, including leading eCRF design and edit check specification development; Robust knowledge and hands-on experience with the set-up, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems for clinical trials; Strong project management skills, including developing and managing timelines, prioritizing competing deliverables, monitoring quality, identifying risks, and driving issues to resolution; Strong knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11 expectations, and industry standards applicable to clinical data management; Working knowledge of CDISC standards, including CDASH and SDTM concepts; Strong analytical, problem-solving, organizational, and decision-making skills with excellent attention to detail; Ability to manage multiple studies and priorities in a fast-paced environment; Excellent written and verbal communication skills and a collaborative, solutions-oriented leadership style; Ability to work on site Monday, Tuesday & Thursday
Nice to have
Scientific or healthcare-related degree preferred; EDC Designer certifications a plus; Experience with eCOA/ePRO, medical coding, safety systems, data warehouses, and data visualization tools is preferred
Benefits
Annual bonus; Significant equity; Generous benefits package
Stany Zjednoczone · New York
