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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, project leadership, and adherence to ICH Good Clinical Practice (GCP) guidelines. Proficient in managing complex clinical research projects while ensuring data quality and compliance with regulatory standards.
Highest-signal resume keywords
Clinical Data ManagementProject LeadershipICH Good Clinical Practice (GCP)Clinical Trial DatabasesTeam Mentoring
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 ManagementDatabase LockElectronic Data Capture (EDC)Project PlanningRegulatory ComplianceMedical TerminologyClinical TrialsTechnical LeadershipData Quality AssuranceResource Management
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsIndependent WorkTeam Collaboration
Tools & Technologies
IBM Clinical DevelopmentMedidata RaveX
Industry Keywords
Clinical ResearchCRO IndustryPharmaceuticalBiotechRegulatory Guidelines
About the role
Key responsibilities & impact- Perform data management tasks from study start-up through database lock for assigned clinical research projects
- Manage paper-based and electronic data capture (EDC) studies
- Ensure overall data quality and documentation on clinical research projects
- Work on mid-to-large complex projects across various indications
- Serve at times as program manager overseeing multiple studies for the same client
- Lead a team of clinical data managers to ensure contracted activities follow Veristat Standard Operating Procedures and/or sponsor-specific requirements
- Promote consistent operations, efficient resource use, knowledge sharing, and best practices with Data Management leadership
- Assist with training data managers on project-specific and general data management processes, procedures, and systems
- Provide training to other company functions as needed
Requirements
What you’ll need- Bachelor’s degree in a related field & 7+ years of relevant experience
- At least 5 years’ experience in clinical data management in a clinical research setting
- 4 years of experience in leading project teams
- Thorough knowledge of ICH Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines
- Knowledge of medical terminology, clinical trials, and clinical research
- Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotech companies
- Demonstrated technical leadership and ability to lead by example
- Ability to serve as an internal and external consultant and influence without authority
- Ability to operate with the “big picture” in mind and advise management
- Expert-level computer skills, including clinical trial databases and applications such as IBM Clinical Development and Medidata RaveX
- Strong desire and ability to learn new applications
- Detailed understanding of project planning and management methods
- Excellent interpersonal, communication, and organizational skills
- Ability to work independently and in a team environment
- Ability to work across projects with differing priorities, mentor teams, and provide data management expertise
Benefits
Comp & perks- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus