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, Abb Vie 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 Abb Vie 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 Planning & Execution Program EP&E Directors, MHI leadership) on study status; ensuring entries in the Clinical Trial Management System (CTMS) are complete and accurate and expected documents are filed in the Trial Master File (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 Abb Vie employees and/or oversight of contractors.

• 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.

Abb Vie 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.

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Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.