Study Project Manager II, Study Management & Execution

Role Summary

The Study Project Manager II (SPM II) for Study Management & Execution ensures excellence in the management and execution of Medical Affairs + Health Impact (MHI) studies, including but not limited to single- and multi-country non-interventional studies and the management and oversight of external research. The SPM II connects functional areas within Medical Affairs and Health Impact (TA BUs/Area/Affiliates) and across different R&D functions to align study deliverables and timelines.

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, Affiliate, Area) and V&E team members, 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 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., EP&E Directors, MHI leadership) on study status; ensuring entries in the CTMS are complete and accurate and expected documents are filed in the TMF.
• Proactively identify and address and/or escalate study related issues; connect with TA-aligned EP&E Program Directors as needed.
• Manages study budget and spend against approved budget; works closely with V&E Operations.
• Ensure inspection readiness and participate in related inspection/audit activities.
• Leads continuous improvement activities/projects, partnering with Business Excellence as appropriate.
• Contributes to team culture of information sharing, team building, and mentoring junior staff.
• May provide direct supervision to AbbVie employees and/or oversight of contractors.

Qualifications

• Bachelor’s Degree or international equivalent required, degree in scientific field preferred.
• Must have at least 8 years of Pharmaceutical industry-related experience or equivalent, or 6 years of related experience with an advanced degree.
• Competent in applying standard quality procedures (SOP, ICH/GCP, Local Regulations).
• Demonstrates a high level of core and technical competencies through management of various components of clinical/medical studies.
• Proven good presentation and communication skills.
• Proven organizational, project management and leadership skills, including ability to successfully facilitate cross-functional team meetings.
• Proven analytical and critical thinking skills; skilled at problem solving at operational and tactical levels.
• Operates independently; escalates issues with proposed action/mitigation plan.
• Capable of meeting changing business and regulatory requirements.
• Experienced at coaching/mentoring in a matrix environment; direct people management desirable.