Study Management Associate II, Oncology Clinical Operations
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 hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They 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. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location.
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 Responsibilities Include :
- Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Supports the Study Project Manager in leading the cross functional study team:
o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
•Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
Supports 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
- Participates in process improvement initiatives
- 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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled