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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, including Data Governance, Data Integrity, and Data Quality, while ensuring compliance with global regulatory requirements. Proven ability to lead teams, manage data processes, and deliver quality results in a fast-paced clinical trial environment.
Highest-signal resume keywords
Clinical Data ManagementData GovernanceData IntegrityData QualityDrug Development Experience
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 ManagementData Handling PlansData Review PlansUser Acceptance TestingDatabase DesignData ValidationData AnalysisData ReportingQuality ManagementProblem-Solving
Soft Skills
Interpersonal SkillsTeam LeadershipEffective CommunicationAgility Under PressureInfluencing Skills
Industry Keywords
Clinical TrialsGlobal Regulatory ComplianceAudit CoordinationContinuous ImprovementOperational Excellence
About the role
Key responsibilities & impact- Provide professional and lean execution of Data Management products and milestones for assigned clinical trials
- Provide Data Management leadership across assigned trials and act as Trial Data Manager where needed
- Demonstrate business understanding of compound profiles to support 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
- Manage quality, 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 standards and documentation
- Generate data-review listings and provide them to study teams when needed
- Generate study status reports for clinical trial team meetings
- Support and assist junior staff on assigned trials
- Contribute to Data Management initiatives, innovation, quality, efficiency, continuous improvement, scientific excellence, and operational excellence
- Lead or coordinate synonym review and dictionary version upgrade activities at trial or program level
- Serve as primary study lead, ensuring timely and quality deliverables through strong 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
- Knowledge of Clinical Data Management, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, and Waterfall Model
