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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, ensuring compliance with global regulatory requirements while leading data management initiatives and supporting trial teams. Proficient in data handling, review, and analysis, with strong interpersonal and problem-solving skills.
Highest-signal resume keywords
Clinical Data ManagementData Handling PlansRegulatory ComplianceInterpersonal SkillsProblem-Solving Skills
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 Management LeadershipDatabase DesignData ValidationUser Acceptance TestingData ReviewSAE ReconciliationData Listings GenerationProcess ImprovementTraining DeliverablesAudit Coordination
Soft Skills
Effective CommunicationTeam LeadershipAgility Under PressureInfluencing SkillsInterpersonal Effectiveness
Industry Keywords
Drug DevelopmentClinical TrialsGlobal EnvironmentData Management InitiativesContinuous Improvement
About the role
Key responsibilities & impact- Provide data management leadership across assigned trials and act as Trial Data Manager where needed
- Demonstrate business understanding of compound profiles to support effective data management processes
- Provide feedback on protocols and amendments
- Identify and resolve protocol issues affecting database design, data validation, analysis, or reporting
- Perform study start-up data management activities, including Data Handling Plans, Data Review Plans, and user acceptance testing
- Manage local laboratory setup for clinical databases where applicable
- Lead process and training deliverables within platforms or processes
- Ensure compliance with global regulatory requirements and business objectives
- Coordinate audit and inspection data operations, exception requests, deviations, and corrective/preventive action plans
- Perform hands-on data management activities throughout the study
- Review clinical study data, including third-party and local laboratory data and SAE reconciliation where applicable
- Ensure consistency of assigned trials with program-level data management documentation standards
- Generate data listings for review and study status reports for clinical trial team meetings
- Support and assist junior staff on assigned trials
- Contribute to data management initiatives, innovations, quality, efficiency, and continuous improvement
- Lead or coordinate synonym reviews and dictionary version upgrades at trial or program level
- Serve as primary study lead, maintaining relationships with study teams and functional lines
- Act as a technical consultant as required
Requirements
What you’ll need- Ability to work under pressure demonstrating agility through effective and innovative team leadership
- Excellent interpersonal skills and proven ability to operate effectively in a global environment
- Ability to influence and communicate across functions and to external stakeholder
- Proven ability to interrogate and view data through various programming/GUI techniques
- Excellent problem-solving skills
- Ideally 4 years’ experience in Drug Development with at least 3 years in Clinical Data Management
- Excellent verbal and written skills
