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Study Management Associate II/III - Multiple Therapeutic AreasUSA, Illinois, Lake CountyNewResearch & DevelopmentRequisition #2001436This role can be hired at a SMA II or a SMA III level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilitiesLocation: This role is based out of AbbVie’s HQ in North Chicago, IL. While some openings require full-time or part-time office-based employment, there are some openings where a full-time remote/home-based or AbbVie Affiliate-based employment arrangement is possible.Matrix management of functional areas and/or study vendors to ensure clinical study(ies) execution occurs per timelines. Individual is aware of both internal and external business environments and their impact on studies and escalates performance issues to management with possible solutionsKey Responsibilities Include:
Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
Supports the Study Project Manager in leading the cross functional study team
Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
Proactively identify and resolve and/or escalate study related issues
Participates in process improvement initiatives
Study Management Associate II Requirements:
Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable
Two years of Pharma-related/clinical research related experience or professional equivalent desired.
Demonstrates analytical and critical thinking skills.
Possesses good communication skills.
Study Management Associate III Requirements:
Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
Possesses good communication skills.
Competent in application of standard business procedures (Standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance).
Preferred exposure to study initiation through study completion
At AbbVie we offer comprehensive benefits, 3 weeks paid vacation, 11 Company holidays, 3 personal days, a 401k, pension plan and a great place to work.Additional Information
Significant Work Activities and Conditions: Keyboard use (greater or equal to 50% of the workday), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
Job Level Code: IC
Vacancy expired!