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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 ICH/GCP Guidelines. Proven ability to develop site engagement strategies and mentor less experienced Clinical Research Associates (CRAs) while ensuring quality outcomes in a dynamic environment.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP GuidelinesSite Evaluation and TrainingCross-Functional CollaborationRisk-Based 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 ManagementSite MonitoringPatient RecruitmentData SubmissionRegulatory ComplianceRisk AssessmentSite Closure ActivitiesTherapeutic Area KnowledgeInvestigator EvaluationQuality Standards
Soft Skills
Interpersonal SkillsOrganizational SkillsActive ListeningPresentation SkillsCritical Thinking
Tools & Technologies
CRM ToolsMonitoring PlansAudit Readiness Tools
Industry Keywords
Clinical ResearchInvestigational Drug TrialsHealth-Related DisciplinesRegulatory Inspection ReadinessAbbVie SOPs
About the role
Key responsibilities & impact- Advance AbbVie’s clinical research pipeline by turning science into medicine and leveraging advanced capabilities
- Serve as the primary point of contact for investigative sites
- Provide clinical trial context and connect stakeholders with investigative sites
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
- Conduct site evaluation, training, routine monitoring, and site closure activities
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
- Develop and customize site engagement strategies and use CRM tools to track progress and measure impact
- Support effective patient recruitment and retention based on the patient disease journey
- Develop knowledge of the therapeutic area, clinical asset, clinical landscape, and patient journey
- Mentor and train less experienced CRAs and contribute to their development
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and clinical trial sites
- Ensure quality and timely submission of site data and safety-event reporting
- Maintain audit and regulatory inspection readiness
- Manage investigator payments according to contract obligations, when applicable
Requirements
What you’ll need- Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring experience involving investigational drug or device trials
- Familiarity with risk-based monitoring, including onsite and offsite monitoring
- Knowledge of applicable therapeutic area indications preferred
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong cross-functional collaboration, planning, organizational, interpersonal, written, verbal, active listening, and presentation skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources
- Ability to establish site relationships and trusted partnerships through engagement, motivation, and training
- Ability to apply critical thinking and good judgment to clinical site issues
- Integrity in accordance with AbbVie’s code of business conduct and leadership values
- Self-motivated approach focused on timely, quality outcomes
Benefits
Comp & perks- Paid time off including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Equal opportunity employment
- Reasonable accommodations for US and Puerto Rico applicants
