Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Remote

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.

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), 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.

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the 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.

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

The Senior Manager, Clinical Data Management (CDM) 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.

Responsibilities:

Strategic Leadership & Study Oversight

• Lead Data Management activities across assigned clinical studies and programs, ensuring alignment with study objectives, timelines, and quality expectations
• Serve as the primary sponsor-side Data Management lead and key point of contact for CROs, vendors, and internal stakeholders
• Represent Clinical Data Management on cross-functional study teams and support strategic decision-making related to clinical data
• Establish and monitor study-level data quality metrics, risk indicators, and operational performance measures
• Drive continuous improvement initiatives and contribute to the evolution of Data Management processes and best practices

Operational Excellence Across the Study Lifecycle

• Provide end-to-end oversight of Data Management activities from study start-up through database lock and close-out
• Oversee the development and review of Data Management Plans (DMPs), CRFs/eCRFs, edit check specifications, external data transfer specifications, reconciliation plans, and database documentation
• Collaborate with CRO partners to translate protocol requirements into effective data collection and validation strategies
• Ensure timely execution of data review, query management, reconciliation, coding review, and database lock activities
• Facilitate User Acceptance Testing (UAT) for database builds, migrations, upgrades, and mid-study amendments
• Support development and implementation of data review strategies and risk-based data cleaning approaches

CRO & Vendor Management

• Provide oversight and governance of CROs and external vendors responsible for Data Management activities
• Review and approve key study deliverables, including DMPs, CRFs, edit checks, data transfer agreements, and reconciliation specifications
• Monitor vendor performance, timelines, quality metrics, and contractual obligations
• Conduct regular operational reviews and escalation meetings to proactively address risks and issues
• Ensure external data integrations are completed accurately and efficiently for laboratory, imaging, ePRO/eCOA, and other vendor data sources

Data Systems & Technology Leadership

• Serve as a subject matter expert for Medidata Rave EDC and related clinical data technologies.
• Provide oversight for database design, build review, validation, release readiness, and system enhancements
• Support integration of external data sources and management of clinical data assets across ongoing and historical studies
• Collaborate within Biometrics, and cross functionally to improve data flows, system interoperability, and reporting capabilities
• Champion the adoption of industry standards and innovative technologies that enhance data quality and operational efficiency

Data Quality, Compliance & Inspection Readiness

• Ensure data integrity, traceability, completeness, and consistency throughout the clinical trial lifecycle
• Maintain inspection readiness through oversight of study documentation, TMF quality, and data management records
• Support audits, inspections, and regulatory submissions by ensuring Data Management processes comply with applicable regulations and industry standards
• Ensure adherence to ICH-GCP, applicable regulatory requirements, company SOPs, and data governance standards
• Participate in protocol deviation reviews, risk assessments, and quality management activities

Cross-Functional Collaboration & Leadership

• Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, and external partners
• Provide guidance and mentorship to Data Management professionals and study team members
• Foster a culture of accountability, collaboration, quality, and continuous improvement
• Lead data review meetings and facilitate effective communication of study data status, risks, and mitigation strategies

Resource Planning & Operational Management

• Support forecasting of Data Management resource needs across assigned studies and programs
• Contribute to vendor selection, scope development, budget planning, and resource allocation discussions
• Monitor study deliverables to ensure efficient utilization of internal and external resources
• Support departmental initiatives, metrics reporting, and strategic operational planning

Qualifications:

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related field
• Minimum of 8+ years of progressive Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industry
• Minimum of 3+ years of experience as a Data Management Lead overseeing outsourced clinical trials
• Demonstrated experience managing multiple studies and vendor relationships simultaneously
• Strong knowledge of clinical trial conduct, data management methodologies, database lifecycle management, and industry best practices
• Experience with Medidata Rave EDC; familiarity with additional EDC systems as well as data review tools such as Elluminate
• Strong understanding of external data integrations, database builds, validation activities, and database lock processes
• Working knowledge of CDISC standards, including SDTM and CDASH
• Experience supporting regulatory inspections, audits, and submission readiness activities
• Excellent communication, stakeholder management, leadership, and problem-solving skills
• Ability to work independently while effectively influencing cross-functional teams and external partners

Preferred Qualifications:

• Experience in CNS, psychiatry, neuroscience, or other complex therapeutic areas
• Experience with ePRO/eCOA, IRT/RTSM, coding systems, imaging systems, and laboratory integrations
• Medidata Rave certification or advanced platform experience
• Experience with clinical data visualization and reporting tools such as Elluminate, Spotfire, Power BI, Tableau, SAS JMP, or equivalent
• Experience developing or improving SOPs, work instructions, and operational standards
• Working knowledge of data programming or analytics tools such as SQL, R, or Python
• Experience supporting NDA, BLA, MAA, or other regulatory submissions

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.

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:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous