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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial data management, including Electronic Data Capture (EDC), data reconciliation, and compliance with GCP standards. Proven ability to lead cross-functional teams, manage client relationships, and ensure project timelines are met while maintaining high-quality data integrity.
Highest-signal resume keywords
Clinical Trial Data ManagementElectronic Data Capture (EDC)Sponsor ManagementData ReconciliationProject Timeline Management
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 ManagementBiometricsClinical OperationsData ValidationProtocol Deviation ReconciliationTime ManagementMedical TerminologyEDC Data CleaningStatistical AnalysisRisk Identification
Soft Skills
CommunicationInterpersonal SkillsTeam CollaborationOrganizational SkillsMentorship
Tools & Technologies
Veeva EDCECOAIRTSAS ProgrammingDatabase Management Systems
Industry Keywords
Good Clinical Practice (GCP)Clinical Trial ProcessScope of Work ManagementClient SatisfactionProject Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead clinical studies involving healthy volunteer and patient populations, multi-site studies, client management, and reduced timelines
- Take accountability for all data management deliverables, study-team instructions, output review, and resource allocation
- Ensure projects comply with protocols, global harmonized SOPs, and GCP standards
- Build project timelines with Project Managers and cross-functional leads
- Lead data-focused internal project team meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK
- Identify risks and mitigations, communicate data-driven discussions, and support database lock dates
- Monitor Biometrics deliverables and advise on impacts to data management resources and deliverables
- Keep Project Managers, Biometrics management, sponsor services, and sponsors informed of project information
- Develop client relationships and review client satisfaction surveys
- Track scope changes and obtain Sponsor approval with the Project Manager
- Provide leadership, mentorship, and coaching in clinical trial data management processes
- Support performance evaluations and provide constructive career-development feedback
- Learn new data management technologies and applied processes and identify process improvements
- Maintain accurate work records
- Reconcile clinical databases against safety, laboratory, and third-party data
- Represent Data Management and Biometrics in new business opportunities
- Attend and action client or internal audits and resolve issues
- Promote Biometrics services to sponsors
- Perform EDC database UAT and data validation listings
- Reconcile external data, communicate with vendors, and resolve queries
- Perform EDC data cleaning, raise queries, maintain issue logs, and upload documents to eTMF
- Report metrics at team meetings
- Perform protocol deviation reconciliation and assist with database lock tasks
- Perform other duties as assigned
Requirements
What you’ll need- University / college degree
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree
- Fluent in English, both written and verbal
- Approximately 3 years in a primary data management role in complex in-house studies, or 5+ years supporting hands-on data review and reconciliation of EDC, Vendors, eCOA, IRT, SAE's, etc.
- 6 to 8 years of DM experience with minimum of 1 year of direct sponsor management
- Experience in in-house study start-up, conduct, and closeout
- Experience handling customer concerns and managing Scope of Work and budgets preferred
- Knowledge of clinical trial process, data management, clinical operations, biometrics, and system applications
- Time management skills and ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment and collaborate with peers
- Good organizational, communication, interpersonal, team working, and collaboration skills
- Knowledge of medical terminology
- University / college degree in life sciences, health sciences, information technology or related subjects preferred
- Knowledge of science or a scientific background preferred
- Thorough knowledge of Fortrea, organizational structure, and SOPs
- 3+ years of Electronic Data Capture experience
- Prior Veeva EDC experience is a plus
- Willingness to work flexible shifts, overtime, and weekends as required
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(K)
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
- Office and home-based work environment
- Flexible shifts as per business requirement
