Study Management Associate II/III (Clinical Research Associate)
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.
We are currently growing our Clinical Operations team at Stemcentrx, AbbVie's site in South San Francisco, CA and we are looking for individuals with clinical operations/development experience within the pharmaceutical and/or biotech industry. The ideal candidate will demonstrate a high level of core and technical competencies within the management of clinical trials in the Oncology therapeutic area. You will be contributing to developments on the leading edge of cancer research within the pharmaceutical industry and will be part of a nimble, biotech -like environment within a large, well established pharmaceutical company. The ability to lead cross-functional teams for multiple studies in a matrix environment and direct management experience is expected.
- Responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion (i.e., Clinical Study Report - CSR finalization)
- Matrix manage assigned cross-functional study team members to ensure compliance and execution of deliverables within approved budget and timeline
- Manage the implementation, on-time execution and conduct of clinical studies; including the development of key milestones and timelines; determining study costs, and resource needs (including vendor selection) as well as ensuring quality and compliance throughout the duration of the study
- Prioritize activities to ensure study goals are met
- Lead study activities such as protocol and informed consent preparation, investigator selection, site budget/contract development, investigator meeting, vendor selection, eCRF design, vendor specification review/approval, and monitoring oversight
- Provide input on regulatory documents from Investigational New Drug (IND), and Clinical Trial Applications (CTAs) to Clinical Study Reports (CSRs) and Biologic License Applications (BLAs)
- Effectively communicate study progress and proactively identify issues that potentially impact evaluable study data, ethical study conduct, Code of Federal Regulations or other local regulations/guidelines and International Conference on Harmonization/Good Clinical Practice (ICH-GCP) compliance and identify potential interventions or solutions to manage/mitigate the issues
- Aware of both internal and external business environments, assess the impact on clinical studies and make modifications as necessary to sites/vendors after comparing invoice against an executed contract.
Position will be hired based on level of experience
- Study Management Associate III: Bachelor's Degree or equivalent is required, typically in nursing, medical or scientific field. An Associate's degree/R.N. or equivalent with relevant experience is acceptable; and 4+ years of pharmaceutical or biotech-related/clinical research related experience.
- Study Management Associate II: Bachelor's Degree or equivalent is required, typically in nursing, medical or scientific field. An Associate's degree/R.N. or equivalent with relevant experience is acceptable; and 1+ years of pharmaceutical or biotech-related/clinical research related experience
- Demonstrate a high level of core and technical competencies through management of various components of clinical trials
- Possess good communication skills and demonstrated leadership abilities
- Competent in application of standard business procedures (SOPs, ICH-GCP, Global Regulations, Ethics and Compliance
- Experience in study initiation through study completion is preferred.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled