Senior Clinical Data Manager – Contract

BioCryst Pharmaceuticals, Inc.

. Develop and manage all aspects of the global clinical study data management process from study start-up through database lock and regulatory submission support .

Posted 10/17/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management processes, including database management, data cleaning, and regulatory submission support. Proficient in utilizing Medidata Rave EDC software and managing clinical trials across various phases while ensuring data quality and compliance.

Highest-signal resume keywords

Clinical Data ManagementMedidata Rave EDC SoftwareData Cleaning and Query ManagementRegulatory Submission SupportCollaboration Across Functional Disciplines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ManagementDatabase LockingInterim AnalysesClinical Study ReportsData Listings DevelopmentLaboratory Data ManagementECRF ManagementSOP DevelopmentMetrics ReportingRisk Identification

Soft Skills

Excellent CommunicationTime ManagementAutonomous WorkInitiative TakingCollaboration

Industry Keywords

Phase I TrialsPhase II TrialsPhase III TrialsClinical Research OrganizationsData Management ProcessesStudy Start-UpRegulatory ComplianceQuality Data CaptureEDiary ComplianceAudit Readiness

About the role

Key responsibilities & impact

Develop and manage all aspects of the global clinical study data management process from study start-up through database lock and regulatory submission support
Coordinate data management activities with the DM Contract Research Organization, internal and external biostatistics, laboratory vendors, database programming, and trial operations
Develop, run, review, and maintain laboratory and database data listings
Identify risks and flag findings during ongoing studies; develop materials and present to CRAs and sites to support consistent, quality data capture
Lead data cleaning, including issuing queries and providing guidance on query issuance and acceptable closure
Ensure completeness, correctness, and consistency of routine clinical data and its structure
Coordinate weekly reconciliation with multiple vendors for timely and quality data entry, laboratory completion and results, and eDiary entry and compliance
Ensure eCRFs, CCGs, edit checks, SOPs, and DMPs meet study requirements and assist with updates
Support updates to the Medidata Rave EDC system, associated UAT, and documentation
Collaborate with internal teams, CROs, and vendors to meet deliverables and timelines for clinical data acquisition, quality review, clinical study reports, and regulatory submission documents
Collaborate with Statistics and Clinical teams to manage DMC meetings, timelines, data cleaning, EDC and laboratory data transfers, and related activities
Assist the study manager with tracking database interim review and lock timelines and meeting CDM milestones
Develop and maintain report metrics for the study team and upper management, including monitoring trends across regions
Support ad hoc clinical team tasks such as newsletter preparation and CRA training
Support study-level audit and inspection readiness activities as needed
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree with a focus in biological sciences, biometrics, mathematics, etc., or equivalent combination of experience and education
Minimum of 5 years of data management experience, including at least 2 years at a sponsor company
Experience and familiarity with Medidata Rave EDC software
Experience and familiarity with Phase I, II, and III trials, preferably global
Experience and familiarity with interim analyses and freezing and locking databases
Excellent communication and time management skills, including collaboration across functional disciplines
Ability to prioritize study load and associated tasks
Must be autonomous and independent, take initiative, and manage, own, and lead all aspects of data management while contributing to the overall study team

Benefits

Comp & perks

Contract role
Full-time schedule
Equal employment opportunity protections
Commitment to compliance with federal, state, and local law