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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. Possesses strong analytical skills to assess site performance and implement corrective actions while maintaining a customer-focused approach.
Highest-signal resume keywords
Site ManagementClinical MonitoringRegulatory ComplianceData AnalysisClinical Trial Management System
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 ResearchMonitoring SkillsGood Documentation PracticesPatient RecruitmentSite Performance ManagementClinical Trial PhasesGCP/ICH GuidelinesRegulatory DocumentationSite Visit CoordinationProblem-Solving
Soft Skills
Effective CommunicationTime ManagementInterpersonal SkillsConflict ManagementOrganizational Skills
Tools & Technologies
Clinical Trial Management SystemElectronic Trial Master FileMS OfficeClinical IT Applications
Industry Keywords
Bio/PharmaCROClinical Research LawClinical Study ProtocolsSite SelectionAudit and Inspection Activities
About the role
Key responsibilities & impact- Serve as primary site contact and site manager throughout all phases of clinical research studies
- Take overall responsibility for allocated sites and develop strong site relationships
- Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws and regulations, protocols, and monitoring plans
- Gain an in-depth understanding of study protocols and related procedures
- Coordinate tasks to achieve Site Ready status and provide input on site selection and validation
- Perform remote and on-site monitoring and oversight
- Conduct validation, initiation, monitoring, and close-out site visits
- Record accurate visit and non-visit contact reports in a timely manner
- 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, documentation, audits, inspections, and site performance
- Identify, assess, and resolve site performance, quality, and compliance problems
- Escalate issues in collaboration with the Clinical Research Manager and Partner Line Manager
- Manage information and documentation in the Clinical Trial Management System, electronic Trial Master File, and other systems
- Contribute knowledge as a process subject matter expert, buddy, or mentor
- Support or lead audit and inspection activities and perform co-monitoring visits
- Complete required training, submit timesheets and expense reports, update CV, and comply with Parexel and client processes and applicable requirements
Requirements
What you’ll need- Proven skills in site management, including management of site performance and patient recruitment
- A demonstrated high level of monitoring skill with independent professional judgement
- Ability to understand and analyze data and metrics, and to act on them appropriately
- Solution-oriented approach to complex issues, with root cause analysis and implementation of preventive and corrective actions
- Effective time management, organizational, interpersonal, conflict management, and problem-solving skills
- Strong verbal and written communication skills, including ability to understand and present technical information effectively
- Ability to work effectively in a matrix, multicultural environment and build culturally sensitive working relationships
- Customer focus, with a quality and compliance mindset
- Positive, growth mindset and self-driven approach, with ability to work independently
- High sense of accountability and urgency, with ability to set priorities and handle multiple tasks simultaneously
- Good IT skills, including MS Office and clinical IT applications on computer, tablet, and mobile devices
- Fluent in the local language and English, both verbal and written
- Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research law and guidelines
- Good understanding of global and country/regional clinical research guidelines
- Hands-on knowledge of Good Documentation Practices
- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Current driver's license
- Ability to travel domestically and internationally approximately 65%-75% of working time, approximately 2-3 days per week
- Bachelor's degree in science (Biotechnology, Pharma, Biology) preferred
Benefits
Comp & perks- Premium salary
- Attractive benefits
- Car or car allowance
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- People who motivate and face challenges together
- Innovative technology
- Excellent training
- Paid time off
- Life insurance
- Health insurance
- Additional benefit offerings in accordance with the terms of applicable plans
- Potential eligibility for additional incentives, bonuses, or other compensation programs