Senior Clinical Trial Associate (NK20-230)
Catalyst Biosciences is seeking a Senior Clinical Trial Associate in our South San Francisco office, reporting to our Director of Clinical Operations. The incumbent will manage the overall operation of our clinical studies including project planning, budget, resource management and CRO management.
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from early discovery to late stage clinical trials.
- Manage daily operations of studies to ensure compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical, manufacturing, regulatory affairs) in order to accurately coordinate clinical study activities
- Coordinate clinical study timelines with project leaders to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Conduct study monitoring visits and co-monitoring visits as needed
- Provide regular updates of study progression to stakeholder
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Management of quality at the investigative sites, vendors and data; maintain clinical study files per ICH guidance
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Assist with data reports, presentations and study documents
- Training for investigators and sites
- Recommends and implements innovative process ideas to impact clinical trials management
**Title/Level to commensurate with experience.
- BA/BS degree with 4 - 5 years clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial management experience
- Understanding of ICH/GCP guidelines and protocol and clinical drug development processes, clinical study design, study planning and management and monitoring
- Experience managing CROs and other vendors
- Demonstrated project management skills and study leadership ability
- Proven leadership skills, executive presence, maturity, emotional intelligence, attention to detail, excellent written and verbal communication, problem solving with various working assumptions, intangible variables and incomplete information