Company Description

The CTM works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager.  The Study Management Associate III (CTM) works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives.“

Job Description

•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: o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) o -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
 

Qualifications

•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.
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Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html