About the job
As a Study Project Manager II (SPM II) at AbbVie, you will bridge the gap between scientific research and operational excellence, overseeing the management and execution of various Medical Affairs and Health Impact (MHI) studies. This role encompasses both single and multi-country non-interventional studies, alongside the management and oversight of external research initiatives. You will play a pivotal role in liaising between functional areas within Medical Affairs and across diverse R&D functions.
Key Responsibilities:
- Lead the planning, management, and execution of MHI non-interventional studies, ensuring adherence to quality standards, including global regulations and AbbVie policies.
- Collaborate with Medical TA (Business Unit, Affiliate, Area) and V&E team members to develop study protocols and related documentation, such as informed consent forms and Clinical Study Reports.
- Direct the cross-functional study team, facilitating team meetings, managing timelines, and ensuring that study milestones are achieved in collaboration with Affiliates.
- In partnership with the MHI study lead, manage vendor selection, define vendor scope, and oversee compliance with AbbVie processes and regulations.
- Create and deliver study-related training for team members, study sites, and selected vendors as needed.
- Regularly update the cross-functional team and stakeholders on study status, ensuring accurate and complete entries in the Clinical Trial Management System (CTMS) and proper documentation in the Trial Master File (TMF).
- Proactively identify and resolve study-related issues while connecting with relevant EP&E Program Directors as necessary.
- Manage the study budget, tracking expenditures against approved budgets and collaborating closely with V&E Operations.
- Ensure readiness for inspections and participate in audit activities as required.
- Lead initiatives aimed at continuous improvement in partnership with Business Excellence.
- Foster a team culture that emphasizes information sharing, team building, and mentoring of junior staff.
- May supervise AbbVie employees or oversee contractors as needed.