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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical data management, including oversight of operations, budget management, and adherence to regulatory requirements. Proven ability to lead teams, improve processes, and communicate effectively with stakeholders.
Highest-signal resume keywords
Clinical Data Management ExpertiseBudget ManagementICH Guidelines KnowledgeCDISC CDASH/SDTM ExperienceTeam Leadership
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Oversee day-to-day clinical data management operations
- Lead allocated teams and manage resources to support growth of Ora’s clinical data management function and team members
- Serve as a clinical data management subject matter expert in cross-functional initiatives
- Perform expert-level customer communication and collaboration
- Support business development capability presentations for prospective and current clients
- Manage department and clinical study budgets to achieve or beat targets
- Liaise with internal and external cross-functional teams, sponsors and vendors
- Participate in proposal and contract writing and negotiation
- Review, write and update standard operating procedures, work instructions, forms and templates
- Continuously improve data management operations to reduce costs and timelines while improving quality
- Manage CDM team resourcing and workload
- Develop, maintain, analyze and report departmental performance metrics and KPIs
- Develop and conduct in-house training and development
- Adhere to Ora’s quality management system, data integrity, business ethics and regulatory requirements
- Keep leadership informed of data management project status
- Participate in business development and strategic planning
Requirements
What you’ll need- Bachelor’s degree in applied or life science and minimum of twelve (12) years of experience in clinical trials, with at least ten (10) years in data management, or equivalent education and work experience
- Advanced degree and direct supervisory experience preferred
- Extensive experience in clinical data management, preferably within a CRO environment
- Record of accomplishment establishing, directing and overseeing data management operations in a dynamic environment
- Experience with budgeting and forecasting, individual and team leadership, process management and project management
- Expert knowledge of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
- CDISC CDASH/SDTM training and experience
- Experience in ophthalmology is a plus
- Programming and medical coding skills are a plus
- EDC experience with Oracle Clinical Life Sciences Suite and iMedNet is a plus
- Ability to set goals, create structure and maintain a focused and collaborative approach to timely, high-quality work
- Ability to communicate and collaborate using authenticity, transparency, resilience and empathy
Benefits
Comp & perks- Fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
- Equal employment opportunity as an Affirmative Action and Equal Opportunity Employer
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trials ExperienceData Management OperationsProject ManagementProcess ManagementMedical Coding SkillsEDC ExperiencePerformance Metrics AnalysisProposal WritingContract NegotiationRegulatory Compliance
Soft Skills
CommunicationCollaborationLeadershipEmpathyResilience
Tools & Technologies
Oracle Clinical Life Sciences SuiteIMedNet
Industry Keywords
CRO EnvironmentOphthalmologyGood Clinical PracticeData IntegrityQuality Management System