Senior Clinical Data Manager, Clinical Data Management

Orion

Senior 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

Tech Stack

Tools & technologies

Google 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Database DesignECRF DevelopmentData Validation RulesMedical CodingQuery ManagementData Transfer AgreementsData SpecificationsReconciliation PlansStatistical AnalysisData Review

Soft Skills

Analytical SkillsProblem-SolvingCommunicationStakeholder Management