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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 compliance with ICH/GCP Guidelines and local regulatory requirements. Proficient in site engagement strategies, risk assessment, and leveraging technology for effective site support.
Highest-signal resume keywords
Clinical Research CoordinationGCP ComplianceSite Engagement StrategiesRegulatory KnowledgeCritical Thinking
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 ManagementData ManagementSite EvaluationPatient Recruitment TechniquesRisk AssessmentTherapeutic Area KnowledgeMonitoring PlansSafety-Event ReportingAudit ReadinessContract Management
Soft Skills
CollaborationPlanningOrganizational SkillsCommunication SkillsIntegrity
Tools & Technologies
CRM ToolsMonitoring Tools
Industry Keywords
ICH GuidelinesGood Clinical PracticesStandard Operating ProceduresClinical Research RegulationsHealth Related Disciplines
About the role
Key responsibilities & impact- Advance AbbVie's clinical research pipeline and turn science into medicine
- Partner with investigators and site staff for effective clinical-trial engagements
- Serve as the primary point of contact for investigative sites
- Provide clinical-trial contextual information 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, site training, routine monitoring, and site-closure activities under supervision
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Customize site-engagement strategies for assigned studies
- Gather site insights and use CRM tools to track progress and measure strategy impact
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
- Conduct continuous risk assessment with the Central Monitoring team
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and sites under supervision
- Ensure quality and timely submission of study-site data and safety-event reporting
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations
Requirements
What you’ll need- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred, or experience or equivalent work experience
- Clinically related experience, preferably in clinical research coordinating or data management
- Knowledge of appropriate therapeutic area indications preferred
- Ability to understand and apply scientific concepts to clinical trial conduct
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Ability to work collaboratively and cross-functionally
- 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
- Critical thinking and good judgment to address clinical site issues
- Strong written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
- Knowledge of clinical research regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs)
Benefits
Comp & perks- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Eligibility to participate in short-term incentive programs
- Remote work availability
- Equal opportunity employment
- Reasonable accommodation for US and Puerto Rico applicants