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 clinical studies to life through the execution of one or more late Phase clinical research studies, including multi-country non-interventional studies, post-marketing observational studies, as well as management and oversight of external collaboration and investigator initiated 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.
- Responsible for executing clinical studies in compliance with quality standards (Global Pharmacoepidemiology Practices, 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 managing timelines and milestones
- Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date.
- Contribute to the development of the clinical study design and associated systems and documents (for example: Informed consent forms / patient authorization forms, eCRFs, IRT, CSR) Responsible for study budget creation and oversight of spend against approved budget
- Responsible for the vendor selection, scope development, management and oversight of external vendors 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.
- 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.
- Manages and facilitates cross functional research review forums including pull through of stakeholder feedback and documentation of meeting outcomes.
- Partners closely with Medical Research Support team creating an inclusive and innovative environment where staff and studies/programs will succeed
- 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.
- 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 peoplemanagement 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 and secondary data analysis and/or in multiple phases of studies.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
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.