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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 trial data management, including project leadership, sponsor relationship management, and compliance with GCP standards. Proven ability to mentor teams, optimize processes, and ensure high-quality deliverables in a fast-paced environment.
Highest-signal resume keywords
Clinical Trial Data ManagementSponsor ManagementTechnical MentoringOncology ExperienceElectronic Data Capture
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 ManagementProject DocumentationData Validation ProceduresClinical OperationsBiometricsSOP WritingRisk IdentificationBudget ManagementScope of Work ManagementDatabase Reconciliation
Soft Skills
LeadershipCommunicationInterpersonal SkillsProblem-SolvingTime Management
Tools & Technologies
Electronic Data CaptureSAS ProgrammingClinical DatabasesBiometrics Services
Industry Keywords
GCP StandardsCRO IndustryPharmaceuticalBiotechnological CompaniesClinical Studies
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead data management on clinical studies from study start-up through database lock
- Take responsibility for project documentation, system setup, data entry, and data validation procedures and processes
- Act as subject matter expert for data management activities in Sponsor relationship meetings
- Understand Sponsor requirements and lead implementation
- Review client-specific processes and drive optimization
- Provide guidance, mentoring, and training to data management staff
- Lead studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, or reduced timelines
- Act as Study Manager accountable for data management deliverables, study team instructions, output review, and resource allocation
- Ensure projects comply with protocols, global harmonized SOPs, and GCP standards
- Build timelines with Project Managers or FSP Leads and coordinate with cross-functional project teams
- Lead data-focused internal project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams
- Identify risks and mitigations, communicate data-driven discussions, and support database lock dates
- Monitor Biometrics deliverables and impacts on data management resources and timelines
- Keep project, Biometrics, and sponsor services management informed of project, budget, scope, and timeline information
- Coordinate receipt and inventory of data-related information from clinical sites and vendors
- Ensure documentation and procedures are completed at project closeout
- Maintain client relationships, review satisfaction surveys, implement action plans, and drive process improvements and training
- Track scope changes and obtain Sponsor approval
- Provide leadership, mentorship, and coaching in clinical trial data management processes and technical capabilities
- Support performance evaluations and provide constructive career-development feedback
- Learn new data management technologies and applied processes and support process improvement
- Ensure service and quality meet DMP and scope-of-work specifications
- Write, review, and update SOPs and related documents
- Maintain accurate work records
- Reconcile clinical databases against safety, laboratory, and other third-party data
- Represent Data Management and Biometrics in new business opportunities and bid defense meetings
- Attend and address client or internal audits and resolve issues
- Develop and implement directional strategy, technical input, training, and mentorship
- Promote Biometrics services to Sponsors
- Perform other related duties as assigned
Requirements
What you’ll need- University / college degree
- Experience and/or education plus relevant work experience, equating to a bachelor's degree accepted in lieu of a bachelor's degree
- Relevant and equivalent experience may be considered in lieu of educational requirements
- Speaking/Writing/Reading: English required
- 8 years of combined early or late-stage DM experience
- Minimum 2 years of direct sponsor management experience
- At least 2 years of technical mentoring experience
- Proven experience handling customer negotiations and managing Scope of Work and budgets
- 3-5 years of Oncology experience required
- Thorough knowledge of clinical trial process, data management, clinical operations, biometrics, and system applications
- Proven ability to lead project strategies and achieve department goals, objectives, and initiatives
- Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotechnological companies
- Time management skills and ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment and collaborate with peers
- Ability to mentor junior department members and provide SME guidance on DM practices
- Experience representing DM in bid defense meetings
- Good organizational, communication, and interpersonal skills
- Constructive problem-solving attitude while deadline focused
- Preferred: University / college degree in life sciences, health sciences, information technology, or related subjects
- Preferred: Four or more years of Electronic Data Capture experience
- Preferred: Thorough knowledge of Fortrea, its organizational structure, and SOPs
- Ability to work in an office or remote-based environment
Benefits
Comp & perks- Remote-based work option
- Potential travel for cross-site support or training needs
- Meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay
- All job offers based on candidate skills and prior relevant experience, applicable degrees/certifications, internal equity, and market data
