Job Description
Company Description Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients, and leveraging advanced capabilities to drive industry-leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements, positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance, and customer experience.
Job Description Serve as the primary sponsor point of contact for investigative sites, demonstrating advanced competency in providing contextual information on clinical trials, connecting stakeholders, and strengthening AbbVie's positioning. Ability to motivate and mentor monitoring staff.
Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles, ensuring trusted partnerships. Support and mentor junior personnel in Site Management activities.
Conduct site evaluations, training, routine monitoring, and site closure activities in compliance with protocols, regulations, GCP, ICH guidelines, SOPs, and quality standards, ensuring patient safety and data quality.
Develop and implement site engagement strategies tailored to each study, utilizing tools to report progress and measure impact. Gather insights and adapt strategies as needed.
Connect study protocols, scientific principles, and clinical trial requirements to daily activities, ensuring effective patient recruitment and retention based on the disease journey. Develop knowledge of therapeutic areas and patient pathways.
Mentor and train less experienced CRAs, support onboarding, and contribute to their development. Participate in global or local task forces and initiatives as assigned.
Proactively assess risks in collaboration with the Central Monitoring team, addressing study performance or patient safety issues, and implementing corrective actions to ensure compliance.
Identify, evaluate, and recommend investigators/sites for clinical studies, demonstrating decision-making expertise and networking capabilities.
Ensure data quality, timely reporting, and audit readiness of study sites. Manage investigator payments according to contractual obligations.
Qualifications Relevant tertiary qualification in health-related disciplines preferred.
At least 3 years of clinical research experience, with 2 years in monitoring investigational trials, familiar with risk-based monitoring and regulatory requirements.
Knowledge of therapeutic areas, scientific concepts, and clinical trial conduct.
Strong communication, collaboration, planning, and organizational skills.
Proficiency with technology and tools supporting clinical site management.
Excellent interpersonal, written, verbal, and presentation skills to build trusted site relationships.
Independent judgment, integrity, and motivation to deliver quality outcomes in a fast-paced environment.
Additional Information AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more information, visit . Applicants seeking accommodations can find details at .
#J-18808-Ljbffr Allergan
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