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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. Possesses strong communication and organizational skills to effectively engage and support investigative sites and stakeholders.
Highest-signal resume keywords
Clinical Trial ManagementSite Evaluation and TrainingICH/GCP Guidelines ComplianceRisk-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 Trial KnowledgeSite MonitoringRegulatory CompliancePatient Recruitment TechniquesScientific Concept ApplicationData Submission ManagementAudit ReadinessInvestigational Drug TrialsSite Closure MonitoringRisk Assessment
Soft Skills
Advanced CommunicationOrganizational SkillsInterpersonal SkillsCritical ThinkingMotivational Leadership
Tools & Technologies
Monitoring ToolsClinical Trial Management SystemsData Tracking SystemsPatient Engagement Platforms
Industry Keywords
Clinical ResearchInvestigational TrialsHealth Related DisciplinesTherapeutic Area KnowledgeCompliance Standards
About the role
Key responsibilities & impact- Serve as the primary sponsor point of contact for investigative sites
- Provide contextual clinical trial information, connect stakeholders with investigative sites, and strengthen AbbVie’s positioning
- 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 onsite and offsite monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards
- Develop and execute customized site engagement strategies; gather site insights and track strategy impact
- Apply clinical trial, scientific, and protocol knowledge to day-to-day trial execution
- Develop recruitment and retention techniques based on the patient disease journey
- Build therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and support onboarding of junior CRAs
- Participate in or lead global and local task forces and initiatives
- Conduct continuous risk assessment with Central Monitoring and address site risk signals
- Ensure preventative and corrective action plans are implemented to mitigate risk and promote compliance
- Identify, evaluate, and recommend potential investigators and sites
- 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
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 in independent clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Advanced communication and superior cross-functional collaboration skills
- Superior planning and organizational skills; ability to work effectively with competing projects and deadlines
- Ability to leverage technology, tools, and resources for customer-centric site support
- Superior written, verbal, active listening, presentation, and interpersonal skills
- Ability to establish site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently apply functional expertise, critical thinking, and judgment to clinical site issues
- Acts with integrity according to AbbVie’s code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes in a fast-paced environment
Benefits
Comp & perks- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives, and serving the community