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 . 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 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 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.

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.

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