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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial activities, ensuring compliance with FDA regulations, GCP, and ICH guidelines, while effectively leading project teams and maintaining client relationships. Proficient in developing internal processes and training requirements to enhance project execution and quality assurance.
Highest-signal resume keywords
Clinical Trial ManagementProject LeadershipClient Relationship ManagementKnowledge of FDA RegulationsClinical Monitoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ExperienceData ManagementElectronic Data CaptureContract ManagementTraining Requirements Documentation
Soft Skills
Verbal CommunicationWritten CommunicationPresentation SkillsIndependent WorkPrioritization
Tools & Technologies
WordExcelPowerPointLMS Systems
Industry Keywords
GCPICH GuidelinesClinical Research ProcessesCROSOPs
About the role
Key responsibilities & impact- Plan, implement, and execute contracted clinical trial activities
- Manage full-scope regional and global projects and lead project teams
- Build and maintain positive client relationships
- Negotiate with clients while maintaining IQVIA Biotech operational processes and project scope
- Review study trends and proactively respond to clients and team members
- Develop early warning systems for project obstacles and create solutions
- Identify, define, and document training requirements in LMS systems and ensure compliance
- Manage change across assigned projects
- Ensure projects follow SOPs, working practices, contracts, and timelines
- Identify processes requiring updates and communicate them to management
- Maintain client relationships, current project reporting, and executive management awareness
- Develop, document, and update internal processes, SOPs, working practices, and quality assurance forms
- Provide project support to managers and oversee delegated support staff activities
- Assist with capability and proposal defense presentations
- Support Contracts and Proposals with final contract execution and CIS documentation
- Participate in performance appraisals by providing feedback on team members
- Maintain knowledge of FDA regulations, GCP, and ICH Guidelines for clinical research
- Provide backup project management coverage during absences
Requirements
What you’ll need- Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization with at least one (1) year management experience OR equivalent level of education and experience
- Previous experience in managing people within a scientific/clinical environment is preferred
- Clinical Monitoring or Data Management experience required
- Excellent and demonstrated verbal and written communication and presentation skills
- Ability to work independently, prioritize and work within a matrix team environment
- Working knowledge of Word, Excel, and PowerPoint required
- Prior experience in electronic data capture preferred
- Experience in contract/timeline management preferred
- Ability to travel domestically or internationally as required
- Knowledge of clinical research processes from Phase I through regulatory submission
- Working knowledge of current ICH GCP guidelines
- Must be able to secure a credit card cosigned by IQVIA Biotech
- Must maintain current currency documentation for IQVIA Biotech SOPs, CAPA completion, and timesheet maintenance
Benefits
Comp & perks- Potential incentive plans, bonuses, and/or other forms of compensation
- Health and welfare benefits
- Home-based work arrangement
- Up to 20% travel, including international travel