Study Project Manager II, Study Management & Execution

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Study Project Manager II (SPM) connects science and operations to ensure excellence in study management and execution of one or more Medical Affairs + Health Impact (MHI) studies, including but not limited to, single and multi-country non-interventional studies, as well as management and oversight of external research. The SPM II plays a key role in connecting functional areas both within Medical Affairs and Health Impact (TA BUs/Area/Affiliates) and across different R&D functions.

Responsibilities:

• Responsible for planning, managing and executing MHI non-interventional studies in compliance with quality standards (Global Regulations, AbbVie policies and procedures).
• In partnership with Medical TA (Business Unit (BU), Affiliate, Area) and V&E team members, the SPM II is responsible for the development of the study protocol and associated documents (e.g., informed consent forms, case report forms, Clinical Study Report, publications).
• Leader of the cross functional study team, including but not limited to, leading study team meetings, managing the critical path, working closely with Affiliates and ensuring study milestones are met.
• In partnership with the MHI study lead, responsible for study-level vendor selection, scope of the vendor activities and oversight of vendors in compliance with AbbVie processes and procedures and applicable regulations (e.g., data management, medical writing).
• As applicable, responsible for generating study-related training for the study team members, study sites and selected vendors.
• Responsible for regular updates to the cross-functional team (including Area/Affiliates, as appropriate) and other stakeholders (i.e. Evidence Pla