Job Description

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

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