Senior Clinical Data Manager

BioCryst Pharmaceuticals, Inc.

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

Posted 10/15/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management processes, including data compilation, cleaning, and regulatory submission support. Proficient in utilizing Medidata Rave EDC software and managing clinical trial data across various phases.

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 CompilationData TrackingData MaintenanceDatabase Lock ManagementInterim AnalysisClinical Study ReportsECRF ManagementSOP DevelopmentData Metrics ReportingQuality Review

Soft Skills

Excellent CommunicationTime ManagementAutonomous WorkInitiativeCollaboration

Industry Keywords

Clinical TrialsPhase I TrialsPhase II TrialsPhase III TrialsContract Research OrganizationData Management ProcessesRegulatory ComplianceStudy Audit ReadinessBiological SciencesBiometrics

About the role

Key responsibilities & impact

Develop and manage all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support
Coordinate activities with the DM Contract Research Organization (CRO), internal and external BioStats, laboratory vendors, database programming and trial operations to define and implement data management requirements
Develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization
Develop, run, review, and maintain data listings for laboratory and database data
Identify risks and flag findings during ongoing studies to clinical management
Develop materials and present to CRAs and sites to ensure consistent, quality data capture
Facilitate and 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, lab completion and resulting, and eDiary data entry and compliance
Ensure eCRFs, CCGs, Edit Checks, SOPs, and DMPs meet study requirements and assist with updates
Assist with Medidata Rave EDC system updates, associated UAT, and updated documentation
Collaborate with internal team members, CROs, and vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, regulatory submission documents, and other needs
Collaborate with Stats and Clinical teams to manage frequent DMC meetings, including timeline development, data cleaning, and management of EDC and lab data transfers
Aid the study manager in managing and tracking database interim review and lock timelines and ensure CDM project milestones are met
Develop and maintain report metrics for the overall study team and upper management, monitoring trends across regions
Support the clinical team with ad-hoc tasks such as newsletter preparation and CRA training
Support study-level audit and inspection readiness activities
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 DM experience with at least two years at a Sponsor company
Experience and familiarity with Medidata Rave EDC software
Experience and familiarity with Phase I, 2 and 3 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
Chosen candidate must be autonomous, independent and must take initiative to manage, own, and lead all aspects of DM while contributing to overall study team

Benefits

Comp & perks

Equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities