About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. This role can be hired at a SPM I or a SPM II level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities Purpose: Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology early development pipeline. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. In Oncology Early Develoment, the Study Project Manager is responsible to connect science and operations to bring clinical studies to life through the execution of one or more early phase oncology clinical research studies. Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The study project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. Responsibilities: Study Project Manager II: Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Leader of the cross functional study team: o Leads Clinical Study Team Meetings o Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones Responsible for the vendor/CRO selection, scope development, management and oversight of external vendors/CROs in compliance with AbbVie’s processes and procedures and the applicable regulations Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR) Responsible for study budget creation and oversight of spend against approved budget Proactively identify and address and/or escalate study related issues and opportunities for efficiency Decision maker on operational aspects of study execution Participates in innovation and process improvement initiatives Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed Study Project Manager I: Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Leader of the cross functional study team: o Leads Clinical Study Execution Team Meetings o Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones Responsible for the vendor/CRO selection, scope development, management and oversight of external vendors/CROs in compliance with AbbVie’s processes and procedures and the applicable regulations Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR) Responsible for study budget creation and oversight of spend against approved budget Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies Proactively identify and address and/or escalate study related issues and opportunities for efficiency Decision maker on operational aspects of study execution. Participates in innovation and process improvement initiatives. Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed. Qualifications Qualifications: Study Project Manager II: Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable. Must have at least 8 years of Pharma-related/clinical research related experience. Strong background leading oncology clinical trials Experience overseeing fully outsourced clinical trials or experience at a CRO Must have demonstrated a high level of core and technical competencies through management of clinical trials. Possess good communication skills and demonstrated leadership abilities. Demonstration of successful coaching and mentoring in a matrix environment; direct people management preferred. Considered a subject matter expert and competent in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance). Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4). Study Project Manager I: Bachelor’s Degree or OUS equivalent degree is required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable. Must have at least 6 years of Pharma-related/clinical research related experience. Strong background leading oncology clinical trials Experience overseeing fully outsourced clinical trials or experience at a CRO Demonstrates a high level of core and technical competencies through management of various components of clinical trials. Possesses good communication skills and demonstrated leadership abilities. Demonstration of successful coaching/mentoring in a matrix environment. Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance). Preferred exposure in study initiation through study completion in multiple phases of studies. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.