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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in data management, including leadership in Clinical Data Management, project planning, and execution of global studies. Proficient in managing customer relationships, financial tracking, and implementing quality management plans within the clinical drug development process.
Highest-signal resume keywords
Data Management ExpertiseClinical Data Management LeadershipProject ManagementCustomer NegotiationGood Clinical Practices Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ManagementClinical Data ManagementProject PlanningFinancial ManagementData Management Life CycleSAE ReconciliationExternal Data Vendor ReconciliationLaboratory Data ManagementQuality Management PlansRegulatory Guidelines Knowledge
Soft Skills
Effective CommunicationTeam LeadershipMentoringRelationship BuildingProblem Solving
Tools & Technologies
Internal Tracking DatabasesData Management ToolsNew Technology Implementation
Industry Keywords
Clinical TrialsMedical TerminologyPharmacologyAnatomyPhysiologyClinical Drug Development ProcessOperating ProceduresWork Instructions
About the role
Key responsibilities & impact- Independently manage end-to-end delivery of data management services for single- and multi-service projects, ensuring quality, timelines, budget, and customer satisfaction
- Provide data management expertise and leadership to Clinical Data Management teams
- Lead project planning, execution, close-out, financial management, communications, and milestone deliverables
- Serve as Data Team Lead, Program Lead, Customer Site Manager, and/or Subject Matter Expert as needed
- Serve as primary customer contact for data management deliverables
- Manage multiple large global studies or programs and support Data Team Leads
- Manage customer negotiations, timelines, finances, processes, resources, issue escalation, and continuous process improvements
- Coordinate with Data Operations teams to ensure milestones and quality deliverables
- Train, develop, and mentor junior team members
- Independently manage data management service delivery and resolve escalated data issues
- Assign resources and create, review, and approve data management plan documents
- Implement quality management plans, identify root causes, and implement remedial actions
- Lead organizational change and service improvement initiatives
- Serve as a subject matter expert in CDM tasks or technology and as customer site lead
- Maintain internal tracking databases and systems
- Manage statements of work and budgets, review financial reports, track change orders, and support pricing discussions
- Serve as Project Manager for single-service data management projects, including financial tracking, revenue recognition, and invoicing
- Support RFP processes, including document review, pricing, and bid defense
- Lead best-practice teams, communicate lessons learned, and present at workshops
- Manage development and implementation of new technology or tools
- Present at professional conferences and/or publish articles
- Review and provide expert input on operating procedures and work instructions
- Perform other duties as directed by the functional manager
Requirements
What you’ll need- Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
- 7 years direct Data Management experience, including 5 or more years as a CDM project lead
- Equivalent combination of education, training, and experience
- Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle, including large trials of at least 1000 patients
- Demonstrated expert data management skills and advanced knowledge of the data management process, including therapeutic area, DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology
- Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
- Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
- Knowledge of operating procedures and work instructions and the ability to apply them in practice
- Knowledge of Good Clinical Practices and relevant regulatory guidelines
- Comprehensive understanding of clinical drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers
