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Global Study Specialist

Company: AbbVie
Location: Crystal Lake
Posted on: September 15, 2019

Job Description:

Purpose: This is a global role and can be located virtually in various countries. The role serves as a single point of accountability for the Site Management & Monitoring (SMM) study-level deliverables at global level and influences and aligns within Development Operations and other key stakeholders across the organization. Accountable for planning and driving global study-level SMM deliverables by targeted timelines and within budget for their assigned study(ies). Serves as a primary SMM Point of Contact and interface for Study Team and SMM in their assigned study/ies. Job Responsibilities: Drives operational study-level strategy to be executed by SMM Country teams, including risk evaluation and mitigations to establish alignment with overall study planned timelines. Accountable for working with each country LSR/Country/District COM to ensure LBEs fit within the overall study timelines. I dentifies risks to global SMM deliverables and effectively communicates them within SMM (global, area and regional level) and to the study team. Establish risk mitigation and action plan. Works with Country Leaders, study team and other functional areas, as appropriate to drive implementation of mitigation plan. This occurs both at study start and on an ongoing basis. Accountable for working across all countries - ensuring all participating countries are informed and aligned to the overall timelines for the study and receive appropriate info and docs. Partners with applicable stakeholders (CPD, DDC, CTRG, DSS, CDSM and SMM Country leaders, etc.) in developing global plans for SMM deliverables and dependencies. Uses analytics and country intelligence to enhance SMM input into the Country and Site selection process. Member of the Study Team, representing SMM globally. Serves as a primary SMM Point of Contact and interface for Study Team. Attends study team meetings on planning and execution of the clinical programs. Leads sub-team meetings supporting SMM deliverables. Provides Study Team with insights on SMM processes, communication/escalation paths and key contacts. Provides the perspective of the SMM organization, investigators, and patients, for the development of study documents, including, as applicable, CRA training delivery plans and materials, site staff and patient facing material. Accountable for the development of the study monitoring plan (SMP) and delivers SMP related training. Builds collaborative relationships with key stakeholders involved in the clinical study. Leads change management in the adoption of new technologies and processes in the assigned study(ies) conduct to support consistency and operational excellence in SMM overall execution . Develops global SMM lessons learned for the assigned study(ies)with appropriate stakeholders. Shares and implements best practices. Contributes to improving SMM efficiency, which may include participating in Continuous Improvement Initiative(s) . Qualifications: Bachelor's Degree or equivalent OUS degree is required, typically in (para)medical or scientific field. A minimum of 5 years + of industry clinical research experience including 1 years 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. Able to influence without authority in a matrix environment. Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance). Demonstrated good written and verbal communication skills including fluency in English. 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, and thinks proactively.

Keywords: AbbVie, Crystal Lake , Global Study Specialist, Other , Crystal Lake, Illinois

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