Lead Clinical Data Management, Clinical Data Management, R&D, Orion Corporation

Orion Pharma•Boston, MA

4d•$130,000 - $230,000•Hybrid

About The Position

Lead Clinical Data Management provides strategic and operational leadership for clinical data management activities across oncology development programs spanning Phase I–III clinical trials. Reporting to the Head of Clinical Data Management, this role is responsible for ensuring the delivery of high-quality, inspection-ready, and submission-ready clinical data that support development decisions, regulatory submissions, and corporate objectives. Lead Clinical Data Management partners closely with Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, CRO partners, and external vendors to establish data management strategy, drive operational excellence, and ensure consistent application of industry standards and best practices.

Requirements

Degree in Life Sciences, Data Science, Computer Science, Biostatistics, or a related discipline; advanced degree preferred.
10+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
Demonstrated experience leading data management activities across multiple clinical development programs.
Strong expertise with Medidata Rave EDC, database design, external data integration, database lock processes, and clinical data lifecycle management.
Deep knowledge of CDISC standards, including CDASH and SDTM, and their application within global development programs.
Experience managing CROs, external vendors, and complex data streams including imaging, laboratory, ePRO, genomic, and biomarker data.
Experience supporting health authority submissions, inspections, and audit activities.
Experience implementing process improvement, automation, and operational excellence initiatives.
Understanding of AI-assisted data review, automation technologies, and advanced analytics applications within clinical development.
Excellent leadership, communication, collaboration, and strategic thinking skills.

Responsibilities

Provide leadership for clinical data management activities across multiple oncology studies and development programs.
Serve as the senior Data Management representative on cross-functional program teams and contribute to strategic development planning.
Define and implement data management strategies that support efficient study execution, regulatory compliance, and submission readiness.
Lead the design and development of eCRFs, database builds, edit checks, derivations, data review plans, and study-level data management documentation.
Ensure effective integration, reconciliation, and quality oversight of external data sources including laboratory, imaging, ePRO, genomic, biomarker, and safety data.
Drive data quality initiatives and ensure timely resolution of data issues through proactive review, risk-based approaches, and operational metrics.
Lead database lock planning and execution activities and ensure delivery of high-quality datasets supporting statistical analysis and regulatory submissions.
Ensure compliance with CDISC standards, ICH-GCP requirements, applicable regulations, SOPs, and industry best practices.
Serve as the Data Management representative on regulatory inspections, audits, due diligence activities, and health authority interactions related to clinical data management.
Drive continuous improvement initiatives, standardization efforts, and implementation of scalable data management processes across the portfolio.
Lead evaluation and adoption of AI-enabled technologies, automation platforms, and advanced analytics solutions that improve data quality, operational efficiency, query management, and risk detection.
Establish governance and best practices for responsible use of AI-assisted data review and automated workflow solutions within clinical development.
Contribute to department strategy, resource planning, talent development, and organizational objectives established by the Head of Clinical Data Management.