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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical site management, including monitoring, compliance with ICH/GCP, and effective communication with site staff and investigators. Proven ability to analyze data, manage complex issues, and ensure high-quality standards in clinical research.
Highest-signal resume keywords
Clinical Site ManagementOncology Monitoring ExperienceICH/GCP ComplianceData Analysis SkillsRegulatory Documentation Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Performance ManagementPatient RecruitmentGood Documentation PracticesMonitoring SkillsClinical Trial Phases KnowledgeRegulatory Guidelines UnderstandingCTMS ManagementETMF ManagementRoot Cause AnalysisSolution-Oriented Problem Solving
Soft Skills
Effective Time ManagementOrganizational SkillsInterpersonal SkillsConflict ManagementProblem-Solving Skills
Tools & Technologies
MS OfficeClinical IT Applications
Industry Keywords
Clinical ResearchBio/PharmaCROClinical TrialMulticultural Environment
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Act as the primary site contact and site manager throughout all phases of a clinical research study
- Develop strong site relationships and ensure continuity throughout all trial phases
- Perform clinical study site management and monitoring activities in compliance with ICH/GCP, sponsor SOPs, local laws and regulations, protocol, and monitoring plans
- Gain an in-depth understanding of study protocols and related procedures
- Coordinate tasks with sponsor roles to achieve Site Ready
- Participate in site selection and validation activities
- Perform remote and on-site monitoring and oversight activities
- Ensure site data are complete, accurate, and unbiased
- Protect subjects’ rights, safety, and well-being
- Conduct validation, initiation, monitoring, and closeout visits and prepare timely, accurate reports
- Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
- Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance
- Identify, assess, resolve, and escalate site performance, quality, or compliance issues
- Manage information and documentation in CTMS, eTMF, and other systems
- Contribute to CRA team knowledge as a process subject matter expert, buddy/mentor, and by sharing best practices
- Support or lead audits and inspection activities
- Perform co-monitoring visits where appropriate
Requirements
What you’ll need- Fluent in local languages and English (verbal and written)
- Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research laws and guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines
- Hands-on knowledge of Good Documentation Practices
- Proven site management skills, including site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgement
- Good IT skills, including MS Office and clinical IT applications
- Ability to understand and analyze data/metrics
- Ability to manage complex issues and work in a solution-oriented manner
- Root cause analysis and preventative/corrective action skills
- Effective time management, organizational, interpersonal, conflict management, and problem-solving skills
- Ability to work independently across multiple protocols, sites, and therapy areas
- Ability to set priorities and handle multiple tasks simultaneously
- Ability to work effectively in a matrix multicultural environment
- Commitment to customer focus and quality/compliance
- Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week
- Current driver’s license required
- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Oncology monitoring experience required
- Bachelor’s degree preferred with a strong emphasis in science and/or biology
Benefits
Comp & perks- Full-time employment
- Remote work arrangement
- Equal opportunity employment