Senior Manager, Clinical Data Management

Generate Biomedicines

. Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables .

Posted 9/18/2026full-timeRemote • United StatesSenior💰 $140,000 - $196,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management, including hands-on experience with Medidata Rave EDC, data validation, and database testing. Proficient in managing study timelines, ensuring data quality, and collaborating with cross-functional teams to support clinical studies.

Highest-signal resume keywords

Medidata Rave EDCClinical Data ManagementData Validation PlansICH-GCP ComplianceDatabase Testing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management StrategiesDatabase DesignEdit ChecksECRF SpecificationsUAT TestingData ReviewQuery ManagementExternal Data ReconciliationStatistical ProgrammingData Cleaning

Soft Skills

Excellent Communication SkillsOrganizational SkillsPrioritization SkillsAttention to DetailMultitasking Ability

Tools & Technologies

Medidata RaveECOARTSMRave ReportsDatabase Build Documentation

Industry Keywords

Pharmaceutical IndustryBiotechnologyCRO IndustryClinical StudiesRegulatory Requirements

About the role

Key responsibilities & impact

Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables
Review and approve Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation
Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration
Create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight
Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT
Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables
Monitor data quality, metrics, and study timelines to identify risks early; support external data integrations, transfer specifications, reconciliation activities, and inspection readiness
Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct
Provide updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate
Review CRO financial reports, change notifications, and data management expenses for scope, budget, and timeline oversight
Contribute to continuous improvement of data management processes, standards, tools, and templates

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline
At least 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry
Required hands-on experience with Medidata Rave EDC, eCOA and RTSM
Demonstrated experience creating, running, reviewing, and interpreting Medidata Rave reports and listings
Demonstrated experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting
Solid understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes
Strong knowledge of ICH-GCP and applicable regulatory requirements
Experience reviewing CRO study finance reports, change notifications, and data management expenses
Excellent written, verbal, and interpersonal communication skills
Strong organizational and prioritization skills, with the ability to multitask, manage competing deadlines, and maintain attention to detail

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package
Equal employment opportunity