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.
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
Our research scientists, clinicians, marketing, operations and corporate professionals combine their expertise in 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. Together, we are striving to outsmart cancer.
General Position Summary/Purpose
The Study Management Associate is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.
Key Accountabilities/Core Job Responsibilities
- Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• Support the Study Project Manager in leading the cross functional study team:
- Support the preparation of Clinical Study Team meetings (Agenda/Minutes).
- Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
• Support the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR).
- Support 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 resolve and/or escalate study related issues.
• Participate in process improvement initiatives. Qualifications
- Bachelor's Degree or equivalent required, typically in nursing or scientific field; Associate's degree, R.N. or equivalent with relevant experience is acceptable.
• May have at least 2 years Pharma-related/clinical research related experience or professional equivalent.
• Demonstrates analytical and critical thinking skills.
• Possesses good communication skills.
Yes, 25 % 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.