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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 managing global clinical trials and delivering quality data management services. Proven ability to lead project teams, negotiate with customers, and implement process improvements while maintaining compliance with regulatory guidelines.
Highest-signal resume keywords
Data Management ExpertiseClinical Trial ManagementProject LeadershipCustomer 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 ManagementSAE ReconciliationExternal Data Vendor ReconciliationTherapeutic Area KnowledgeData Management ProcessBudget ManagementQuality Management PlansChange Order TrackingRFP Process Support
Soft Skills
Communication SkillsInterpersonal SkillsCustomer ServiceTeamworkProblem-Solving
Tools & Technologies
Data Management ToolsProject Management SoftwareOperating ProceduresWork Instructions
Industry Keywords
Clinical Drug DevelopmentMedical TerminologyPharmacologyAnatomyPhysiologyGood Clinical PracticesRegulatory Guidelines
About the role
Key responsibilities & impact- Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget
- Provide comprehensive data management expertise to the Clinical Data Management team
- Provide leadership and vision in project planning, execution, close-out, financial management, communications, and milestone deliverables
- Serve as primary customer contact for data management deliverables
- Manage multiple large studies or global programs and support Data Team Leads
- Manage process improvements, issue escalation, workload projections, and technical delivery
- Negotiate timelines, finances, processes, and resources with customers
- Maintain customer relationships and meet contractual obligations
- Coordinate with Data Operations teams to meet milestones and quality requirements
- Train and develop junior team members; mentor and coordinate junior DTL staff
- Establish communications across Data Operations, functional leads, project managers, and stakeholders
- Serve as escalation point for unresolved data issues and coordinate resolutions
- Assign resources and create, review, and sign off data management plan documents
- Implement quality management plans, identify root causes, and implement remedial actions
- Drive organizational change and service improvements across projects or customer accounts
- Serve as Subject Matter Expert, customer site lead, and/or project manager for data management projects
- Manage SOWs and budgets, review financial reports, track change orders, and participate in pricing discussions
- Support RFP processes, including document review, pricing, and bid defense
- Lead best-practice teams, communicate lessons learned, present at workshops or conferences, and contribute to professional publications
- Manage development and implementation of new technologies or tools
- Review and maintain operating procedures and work instructions
Requirements
What you’ll need- Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field
- 5 years of direct Data Management experience with 3 or more years as a CDM project lead
- 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
- Excellent communication, interpersonal, customer service, teamwork, organizational, problem-solving, and project management skills
- Ability to work independently
- Comprehensive understanding of the clinical drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers