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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical data management, including leadership in multi-site studies, client management, and adherence to GCP standards. Proven ability to mentor teams, manage project timelines, and ensure quality deliverables while fostering strong client relationships.
Highest-signal resume keywords
Clinical Data ManagementSponsor ManagementTechnical MentoringElectronic Data CaptureClinical Trial Process
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 DeliverablesProject ManagementBudget ManagementClinical OperationsBiometrics MonitoringSOP WritingDatabase ReconciliationRisk IdentificationQuality ReviewProcess Improvement
Soft Skills
LeadershipCommunicationInterpersonal SkillsProblem-SolvingTime Management
Industry Keywords
GCP StandardsCRO IndustryBiotechnologyPharmaceuticalScope of Work
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead clinical data management studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, and reduced timelines
- Take accountability for all data management deliverables and provide direction and quality review for DM study teams
- Ensure projects follow protocols, global harmonized SOPs, and GCP standards
- Build timelines with Project Managers, FSP Leads, and cross-functional leads to meet contracted milestones
- 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, project progress, budgets, scope changes, and timeline impacts
- Coordinate receipt and inventory of clinical and vendor data and ensure project completion documentation
- Develop client relationships, review satisfaction surveys, implement action plans, and drive process improvements and team training
- Track scope changes and obtain Sponsor approval
- Provide leadership, mentorship, coaching, and technical guidance to DM staff
- Support performance evaluations and career development of team members
- Learn and evaluate new DM technologies and processes for improvement
- Ensure service and quality meet DMP and scope-of-work specifications
- Write, review, and update SOPs and associated documents
- Maintain accurate work records
- Reconcile clinical databases with safety, laboratory, and third-party data using local laboratory systems and batch data loads where appropriate
- Represent DM/Biometrics in business opportunities and bid defense meetings
- Attend and resolve client or internal audit issues
- Promote Biometrics services to sponsors and perform other assigned duties
Requirements
What you’ll need- University / college degree
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- English speaking, writing, and reading 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
- Experience handling customer negotiations
- Experience managing Scope of Work and budgets
- Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations
- Proven ability to lead project strategies and 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: knowledge of Fortrea organization and SOPs
Benefits
Comp & perks- 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
- Compensation considers skills, prior relevant experience, applicable degrees/certifications, internal equity, and market data
