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Senior Manager, Clinical Data Management
UltragenyxSenior Manager in Clinical Data Management leading data management for clinical studies at a biopharmaceutical company. Responsible for program deliverables, vendor management, and cross-functional collaboration.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial data management, including vendor management, electronic data capture systems, and adherence to industry standards such as CDISC/CDASH. Proven ability to lead cross-functional teams, manage timelines, and ensure data quality throughout the data management process.
Highest-signal resume keywords
Clinical Trial Data ManagementVendor ManagementElectronic Data Capture SystemsCDISC/CDASH ImplementationData Quality Assurance
ATS Keywords
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Hard Skills
Data ManagementProgram Development StrategyTimeline NegotiationData Transfer AgreementsMetrics ReportingECRF DesignUser Acceptance TestingAnnotated CRFs ReviewData Management PlansDB Go Live Documentation
Soft Skills
Proactive CommunicationProblem SolvingAdaptabilityTeam LeadershipCreative Decision Making
Industry Keywords
Pharma IndustryBiotech IndustryCROFSPData Management StandardsClinical TrialsQuality DeliverablesKey Performance MetricsCross-Functional CollaborationData Capture
Tech Stack
Tools & technologiesGo
About the role
Key responsibilities & impact- Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
- Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed.
- Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.
- Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications.
- Facilitate and perform cross-functional sponsor EDC user acceptance testing.
- Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.
- Facilitate the development and implementation of key data and metrics reports/listings.
- Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation.
Requirements
What you’ll need- Bachelor’s degree or higher in the scientific, biological, statistical, or computer science field or related discipline.
- Minimum 5-8 years of clinical trial data management experience in the pharma/biotech industry.
- Strong experience in CRO, FSP and vendor management with consistent track record of on-time quality deliverables.
- Extensive technical experience using electronic data capture systems.
- In-depth knowledge of DM industry standards, best practices, and CDISC/CDASH implementation.
- Ability to adapt and manage competing and rapidly changing priorities.
- Effective in proactively identifying issues and driving team towards creative solutions and smart decisions.
Benefits
Comp & perks- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans