Study Project Manager II
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.
The Study Project Manager is responsible to connect science and operations to bring evidence generation to life through the execution of one or more Evidence Solutions GMA non-interventional research studies. Contributes operational strategies to ensure 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, critical thinking, a global mindset, and innovative solutions to address risks and challenges.
- Responsible for executing non-interventional studies in compliance with quality standards (Global Regulations and AbbVie policies and procedures).
- Member of the cross functional study team responsible for facilitating and communicating study-wide information internally and externally inclusive of leading global team meetings
- Project manager for studies and management of critical path and milestones
- 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 and maintenance of the study design and associated systems and documents (for example: Informed consent forms, eCRFs, eTMF, CSR)
- Responsible for study budget oversight of spend against approved budget
- Responsible for the vendor management and oversight in compliance with AbbVie’s processes and procedures and the applicable regulations
- Responsible for generating and delivering study related training for the study team and vendors for assigned studies
- Proactively identify and address and/or escalate study related issues and opportunities for efficiency
- Decision maker within assigned operational aspects of study execution. Participates in innovation and process improvement initiatives.
- Other activities as assigned
- 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.
- Demonstrates a high level of core and technical competencies through management of various components of clinical trials
- Ability to effectively manage multiple competing priorities in alignment with leadership expectations
- Possesses excellent communication skills and able to demonstrate critical thinking and leadership abilities
- Demonstration of successful stakeholder management in a matrix environment
- Competent in application of standard business procedures to research operations (Standard Operating Procedures, Global Regulations, Ethics and Compliance).
- Preferred exposure in study initiation through study completion in multiple phases of study lifecycle; experience with direct oversight and management of global trials preferred
- Preferred experience with Oncology study execution
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.