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Senior Clinical Data Manager, Clinical Data Management
OrionSenior Clinical Data Manager overseeing data management activities for oncology clinical trials. Collaborating with cross-functional teams to ensure quality and compliance in clinical data management.
Posted 7/10/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $80,000 - $150,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management for oncology studies, including database design, eCRF development, and compliance with CDISC standards. Proven ability to lead cross-functional teams and manage complex data streams while ensuring submission readiness and regulatory compliance.
Highest-signal resume keywords
Clinical Data ManagementMedidata Rave EDCCDISC StandardsICH-GCP RequirementsData Quality Improvement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Database DesignECRF DevelopmentData Validation RulesMedical CodingQuery ManagementData Transfer AgreementsData SpecificationsReconciliation PlansStatistical AnalysisData Review
Soft Skills
Analytical SkillsProblem-SolvingCommunicationStakeholder Management
Tools & Technologies
AI-Enabled SolutionsAutomation PlatformsVisualization Tools
Industry Keywords
OncologyPharmaceutical IndustryBiotechnologyCRO IndustryClinical Trials
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead all clinical data management activities for one or more oncology clinical studies from protocol development through database lock and study closeout
- Serve as the primary Data Management representative on cross-functional study teams and act as the main point of contact for data management-related activities
- Lead the design, review, and implementation of eCRFs, database builds, edit checks, derivations, and data validation rules in alignment with study protocols and regulatory requirements
- Lead the integration and reconciliation of external data sources including laboratory, imaging, safety, ePRO, genomics, biomarker, and other vendor datasets
- Develop and maintain Data Management Plans, Data Transfer Agreements (DTAs), data specifications, reconciliation plans, and study-level documentation
- Responsible for query management, discrepancy resolution, medical coding (MedDRA, WHODrug), and SAE/PV reconciliation
- Drive database lock planning and execution to ensure timely delivery of high-quality, submission-ready datasets
- Ensure compliance with CDISC standards (CDASH and SDTM), ICH-GCP requirements, SOPs, and applicable regulatory guidance
- Support regulatory submissions, inspection readiness activities, audits, and health authority requests
- Identify opportunities to improve data quality, process efficiency, and operational scalability through automation and standardization initiatives
- Partner with cross-functional stakeholders to evaluate AI-enabled solutions that support automated data review, query prioritization, risk identification, and operational efficiency
Requirements
What you’ll need- Degree in Life Sciences, Data Science, Biostatistics, Computer Science, or a related discipline
- 5+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry, oncology preferred
- Demonstrated experience serving as a lead data manager for Phase I–III clinical studies
- Strong expertise with Medidata Rave EDC, database design, eCRF development, edit checks, and clinical data review
- Experience managing external vendor data and complex data streams, including imaging, genomics, biomarker, laboratory, and ePRO data
- Strong knowledge of CDISC standards, including CDASH and SDTM
- Deep understanding of ICH-GCP requirements, clinical trial processes, and regulatory expectations
- Experience supporting database lock, submission readiness, inspections, and audit activities
- Strong analytical, problem-solving, communication, and stakeholder management skills
- Interest in emerging technologies, including AI-assisted data review, automation, and advanced analytics applied to clinical development
- Experience with visualization, automation platforms, or AI-enabled data quality solutions is preferred.
Benefits
Comp & perks- Continuous learning opportunities
- Clear purpose in work impacting millions of lives
- Environment valuing teamwork and low hierarchies