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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including site evaluation, training, and compliance with GCP and ICH guidelines. Proven ability to mentor junior staff and develop effective site engagement strategies while ensuring quality outcomes.
Highest-signal resume keywords
Clinical Trial ManagementGCP ComplianceSite MonitoringRisk-Based MonitoringCross-Functional Collaboration
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 Research MonitoringSite EvaluationPatient Recruitment TechniquesRegulatory ComplianceScientific Concepts Application
Soft Skills
Advanced Communication SkillsPlanning and Organizational SkillsCritical ThinkingIntegritySelf-Motivation
Tools & Technologies
Monitoring ToolsClinical Trial Management Systems
Industry Keywords
ICH GuidelinesGCPInvestigational Drug TrialsTherapeutic Area KnowledgeAudit Readiness
About the role
Key responsibilities & impact- Serve as the primary sponsor point of contact for investigative sites
- Provide contextual information on clinical trials and connect stakeholders with investigative sites
- Align, train and motivate site staff and principal investigators on trial goals, protocols and patient treatment principles
- Support, guide and mentor junior personnel on site management activities
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards
- Customize site engagement strategies and track progress, impact and local/site insights
- Apply scientific principles, clinical trial requirements and therapeutic-area knowledge to trial execution
- Develop recruitment and retention techniques based on the patient disease journey
- Mentor and train less experienced CRAs and support local onboarding
- Participate in or lead global and local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to detect study performance or patient safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend investigators and sites for clinical studies
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
- Perform additional activities assigned by the manager
Requirements
What you’ll need- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically related experience
- Preferably 2 years of independent clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications and ability to understand and apply scientific concepts to clinical trials
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Advanced communication and cross-functional collaboration skills
- Planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources for customer-centric site support
- Excellent written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Ability to independently address clinical site issues using functional expertise, critical thinking and good judgment
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
- Full-time availability
Benefits
Comp & perks- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
