Clinical Trials Manager

Location
South San Francisco, CA
Posted
Mar 12, 2019
Ref
FD19-193
Required Education
Bachelors Degree
Position Type
Full time

Catalyst Biosciences is seeking a Clinical Trials Manager in our South San Francisco office, reporting to the Senior Director, Clinical Operations. The incumbent will manage the overall operation of our clinical studies including project planning, budget, resource management and CRO management.

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


Qualifications/Skills Required:
 

  • 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
  • Demonstrated skills in Catalyst’s Core Competencies:
  • Experience working on global project teams preferred
  • Leadership
  • Drive, Intensity, Enthusiasm
  • Goal Orientation/Commitment to Task/Follow-up
  • Teamwork
  • Attention to Quality & Detail
  • Decision Making & Problem Solving
  • Flexibility
  • Ownership & Accountability
  • Experience working on global project teams preferred

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume, referencing requisition number FD19-193 in the subject line.