Global Site Management Lead (Clinical Operations)About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at our website.Purpose:The Global Site Management Lead (GSML) reports into the TA Director, Global Site Management and provides leadership and content expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies.
The role serves as a single point of accountability for global CSM study-level deliverables and influences and aligns within Clinical Development Operations and other key stakeholders across the organization.Primary Responsibilities:Develops and drives operational study-level strategy to be executed by CSM Country teams, including risk identification, evaluation, and mitigation.Identifies risks to CSM deliverables and effectively communicates them within CSM and to the Core Study Team.Manages identified risks through the development of effective mitigation and action plans at the study-level.Works with ASML, Country Leaders, and other functional areas to drive implementation of mitigation and action plans.Actively contributes to planning and execution of clinical programs including content of the protocol and study plans.Accountable for CSM study execution and oversight of timeline development and adherence through the study lifecycle.Partners with stakeholders in developing overall study planning for CSM deliverables and dependencies.Ensures CSM Country leaders receive appropriate and timely study information, documentation, and tools.Provides perspective of the CSM organization for the development of study documents.Accountable for site-level risk assessments, risk mitigation execution, and remediation of site-level non-compliance.Serves as the CSM SME for inspection readiness.Leads change management in the adoption of new technologies and processes in the assigned studies.Develops global CSM lessons learned for the assigned studies with appropriate stakeholders.Participates in the vendor selection process and manages clinical site management vendors.Qualifications:Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.A minimum of 5 years of industry clinical research experience including 1 year of monitoring or project management or equivalent experience on a global study.Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).Experience in multiple therapeutic areas or disease state/indications highly desired.Demonstrates a high level of core and technical competencies through management of various components of clinical trials.Possesses good communication skills and demonstrated leadership abilities.Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.Able to work well within a team and autonomously.
Thinks proactively.Travel: Yes, % of the TimeJob Type: ExperiencedSchedule: Full-timeJob Level Code: IC #J-18808-Ljbffr
