Senior Manager, Clinical Operations (CD21-274)

Location
South San Francisco, CA
Posted
May 26, 2021
Ref
CD21-274
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Catalyst Biosciences is seeking an accomplished individual to serve as the Senior Manager, Clinical Operations reporting to our Head 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 the earliest discovery to late-stage clinical trials with the intent of commercialization.

We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development. We expect you to bring an innovative mindset, scientific curiosity, a lot of energy and pragmatism. For more information, please visit www.catalystbiosciences.com.

RESPONSIBILITIES
  • 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 stakeholders
  • 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 education and professional experience.

REQUIREments
  • BA/BS degree with 5 plus 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