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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 data management, including leading project teams and ensuring compliance with ICH GCP guidelines. Proficient in managing complex clinical research projects while promoting best practices and efficient resource use.
Highest-signal resume keywords
Clinical Data ManagementProject Team LeadershipICH GCP GuidelinesClinical Trial DatabasesRegulatory Compliance
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 ManagementClinical ResearchProject PlanningMedical TerminologyData Quality AssuranceDatabase Lock ProceduresElectronic Data CaptureTechnical LeadershipResource ManagementTraining and Mentoring
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsInfluencing Without AuthorityTeam Collaboration
Tools & Technologies
IBM Clinical DevelopmentMedidata RaveX
Industry Keywords
Contract Research OrganizationPharmaceutical IndustryBiotech IndustryClinical TrialsRegulatory Rules
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 as program manager and oversee multiple studies under the same client when needed
- Lead a team of clinical data managers to ensure contracted activities follow Veristat and/or sponsor-specific requirements
- Promote consistent operations, efficient resource use, and knowledge and best-practice sharing 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 experience in a clinical research setting
- 4 years of experience in leading project teams
- Thorough knowledge of International Conference on Harmonisation (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 the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies
- Demonstrated ability to lead by example and provide technical leadership of staff
- Ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes
- Ability to operate with the “big picture” in mind and serve as a thought partner to management
- Expert level skills in computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX)
- 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 on different projects with different priorities, act as team mentor, and provide data management expertise
Benefits
Comp & perks- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans