Senior Manager, Clinical Data Management

🕒 4 days ago

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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 • 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 • 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 • 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 • 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 • 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 • 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

🎯 Requirements

• 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.

🏖️ Benefits

• 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 parental leave and some fun fringe perks!