Senior Manager, Clinical Data Management

<div class="content-intro"><p>Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.&nbsp;&nbsp;</p> <p>Our lead&nbsp;product&nbsp;candidate,&nbsp;lysergide&nbsp;tartrate&nbsp;(our&nbsp;proprietary orally disintegrating tablet form of&nbsp;lysergide&nbsp;(LSD) D-tartrate),&nbsp;represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p>Guided by&nbsp;the recognition&nbsp;that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address&nbsp;the&nbsp;underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.&nbsp;</p> <p>Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!</p></div><p>The <strong>Senior Manager, Clinical Data Management (CDM)</strong> is responsible for providing operational leadership and oversight of clinical data management activities across assigned clinical studies and programs. This role is accountable for ensuring the delivery of high-quality, reliable, and inspection-ready clinical data through effective oversight of CROs, external vendors, and internal stakeholders. The Senior Manager, CDM manages end-to-end data management activities from study start-up through database lock and close-out, ensuring compliance with regulatory requirements, company standards, and study timelines. The individual will serve as the primary Data Management representative on cross-functional study teams and will drive data quality, operational excellence, and continuous process improvement across the clinical development portfolio.</p> <p><strong>Responsibilities:</strong></p> <p><strong>Strategic Leadership &amp; Study Oversight</strong></p> <ul> <li>Lead Data Management activities across assigned clinical studies and programs, ensuring alignment with study objectives, timelines, and quality expectations</li> <li>Serve as the primary sponsor-side Data Management lead and key point of contact for CROs, vendors, and internal stakeholders</li> <li>Represent Clinical Data Management on cross-functional study teams and support strategic decision-making related to clinical data</li> <li>Establish and monitor study-level data quality metrics, risk indicators, and operational performance measures</li> <li>Drive continuous improvement initiatives and contribute to the evolution of Data Management processes and best practices</li> </ul> <p><strong>Operational Excellence Across the Study Lifecycle</strong></p> <ul> <li>Provide end-to-end oversight of Data Management activities from study start-up through database lock and close-out</li> <li>Oversee the development and review of Data Management Plans (DMPs), CRFs/eCRFs, edit check specifications, external data transfer specifications, reconciliation plans, and database documentation</li> <li>Collaborate with CRO partners to translate protocol requirements into effective data collection and validation strategies</li> <li>Ensure timely execution of data review, query management, reconciliation, coding review, and database lock activities</li> <li>Facilitate User Acceptance Testing (UAT) for database builds, migrations, upgrades, and mid-study amendments</li> <li>Support development and implementation of data review strategies and risk-based data cleaning approaches</li> </ul> <p><strong>CRO &amp; Vendor Management</strong></p> <ul> <li>Provide oversight and governance of CROs and external vendors responsible for Data Management activities</li> <li>Review and approve key study deliverables, including DMPs, CRFs, edit checks, data transfer agreements, and reconciliation specifications</li> <li>Monitor vendor performance, timelines, quality metrics, and contractual obligations</li> <li>Conduct regular operational reviews and escalation meetings to proactively address risks and issues</li> <li>Ensure external data integrations are completed accurately and efficiently for laboratory, imaging, ePRO/eCOA, and other vendor data sources</li> </ul> <p><strong>Data Systems &amp; Technology Leadership</strong></p> <ul> <li>Serve as a subject matter expert for Medidata Rave EDC and related clinical data technologies.</li> <li>Provide oversight for database design, build review, validation, release readiness, and system enhancements</li> <li>Support integration of external data sources and management of clinical data assets across ongoing and historical studies</li> <li>Collaborate within Biometrics, and cross functionally to improve data flows, system interoperability, and reporting capabilities</li> <li>Champion the adoption of industry standards and innovative technologies that enhance data quality and operational efficiency</li> </ul> <p><strong>Data Quality, Compliance &amp; Inspection Readiness</strong></p> <ul> <li>Ensure data integrity, traceability, completeness, and consistency throughout the clinical trial lifecycle</li> <li>Maintain inspection readiness through oversight of study documentation, TMF quality, and data management records</li> <li>Support audits, inspections, and regulatory submissions by ensuring Data Management processes comply with applicable regulations and industry standards</li> <li>Ensure adherence to ICH-GCP, applicable regulatory requirements, company SOPs, and data governance standards</li> <li>Participate in protocol deviation reviews, risk assessments, and quality management activities</li> </ul> <p><strong>Cross-Functional Collaboration &amp; Leadership</strong></p> <ul> <li>Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, and external partners</li> <li>Provide guidance and mentorship to Data Management professionals and study team members</li> <li>Foster a culture of accountability, collaboration, quality, and continuous improvement</li> <li>Lead data review meetings and facilitate effective communication of study data status, risks, and mitigation strategies</li> </ul> <p><strong>Resource Planning &amp; Operational Management</strong></p> <ul> <li>Support forecasting of Data Management resource needs across assigned studies and programs</li> <li>Contribute to vendor selection, scope development, budget planning, and resource allocation discussions</li> <li>Monitor study deliverables to ensure efficient utilization of internal and external resources</li> <li>Support departmental initiatives, metrics reporting, and strategic operational planning</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related field</li> <li>Minimum of <strong>8+ years</strong> of progressive Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industry</li> <li>Minimum of <strong>3+ years</strong> of experience as a Data Management Lead overseeing outsourced clinical trials</li> <li>Demonstrated experience managing multiple studies and vendor relationships simultaneously</li> <li>Strong knowledge of clinical trial conduct, data management methodologies, database lifecycle management, and industry best practices</li> <li>Experience with Medidata Rave EDC; familiarity with additional EDC systems as well as data review tools such as Elluminate</li> <li>Strong understanding of external data integrations, database builds, validation activities, and database lock processes</li> <li>Working knowledge of CDISC standards, including SDTM and CDASH</li> <li>Experience supporting regulatory inspections, audits, and submission readiness activities</li> <li>Excellent communication, stakeholder management, leadership, and problem-solving skills</li> <li>Ability to work independently while effectively influencing cross-functional teams and external partners</li> </ul> <p><strong>Preferred Qualifications:</strong></p> <ul> <li>Experience in CNS, psychiatry, neuroscience, or other complex therapeutic areas</li> <li>Experience with ePRO/eCOA, IRT/RTSM, coding systems, imaging systems, and laboratory integrations</li> <li>Medidata Rave certification or advanced platform experience</li> <li>Experience with clinical data visualization and reporting tools such as Elluminate, Spotfire, Power BI, Tableau, SAS JMP, or equivalent</li> <li>Experience developing or improving SOPs, work instructions, and operational standards</li> <li>Working knowledge of data programming or analytics tools such as SQL, R, or Python</li> <li>Experience supporting NDA, BLA, MAA, or other regulatory submissions</li> </ul> <p></p> <p>The starting base pay range for this position is $140,000.00 - $175,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.</p> <p>Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:</p> <ul> <li>100% paid health benefits including Medical, Dental and Vision for you and your dependents</li> <li>401(k) program with company match and vesting after the turn of the first month after your start date</li> <li>Flexible time off</li> <li>Generous parental leave and some fun fringe perks!</li> </ul> <p></p>