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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Research Management, ensuring compliance with ICH GCP regulations and corporate policies while effectively leading and mentoring a team of Clinical Research Associates. Proficient in project management, resource allocation, and operational issue resolution within clinical trial execution.
Highest-signal resume keywords
Clinical Research ManagementICH GCP ComplianceTeam LeadershipProject ManagementCore Trial Management Systems
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 ResearchCRA MonitoringRegulatory ComplianceGood Documentation PracticesCapacity PlanningPerformance ReviewsResource UtilizationOperational Issue ResolutionManpower ReportingProtocol Implementation
Soft Skills
People ManagementTime ManagementOrganizational SkillsInterpersonal SkillsConflict Management
Tools & Technologies
Core Trial Management Systems
Industry Keywords
Clinical TrialsInvestigator MeetingsClinical Research AssociatesLocal RegulationsSOPs
About the role
Key responsibilities & impact- Manage a team of 6–14 Clinical Research Associates
- Ensure study and site performance adheres to local regulations, company SOPs, and ICH GCP
- Provide training, support, mentoring, career development, and performance reviews for CRAs
- Manage low-performance situations and resolve escalated issues
- Allocate work and support efficient resource utilization
- Contribute to capacity planning, manpower reporting, and CRA forecasting
- Coordinate with CRAs, Partner Line Managers, Clinical Research Managers, and other functions on processes and protocol implementation
- Interact with sites to resolve operational issues
- Attend local Investigator Meetings when requested
- Interface with Global Clinical Trial Organization partners on clinical trial execution
- Escalate site performance issues to the Clinical Research Manager and Clinical Research Director
- Liaise with local HR and finance functions
- Ensure CRA compliance with corporate policies, procedures, and quality standards
- Travel up to 50%
Requirements
What you’ll need- Bachelor’s degree in Science
- Minimum of 5 years’ experience within Clinical Research
- Minimum of 3 years’ experience as a CRA monitoring clinical trials
- Line management experience preferred, or at minimum team leader experience
- Fluent in the local language
- Business proficient in English, verbal and written
- Excellent working knowledge of applicable ICH/GCP regulations and Good Documentation Practices
- Expertise in core trial management systems and tools
- Ability to work independently and in a team environment
- Excellent people management, time management, project management, and organizational skills
- Strong leadership, interpersonal, communication, and conflict management skills
- Demonstrated ability to build relationships and communicate effectively with external customers, sites, and investigators
- Up to 50% travel
- Must be a US or Puerto Rico resident
- No visa sponsorship available
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Remote work arrangement
- No relocation
