Clinical Operations SME

Tunnell Consulting   •  

San Francisco, CA

8 - 10 years

Posted 241 days ago

This job is no longer available.


The Clinical Operations Specialist is expected to perform hands-on clinical operations activities with minimal supervision, as well as provide leadership, supervision, and technical guidance to Clinical Research Associates, Clinical Trial Assistants, and contract Clinical Operations personnel.


  • Clinical trial execution and oversight: Oversee implementation of clinical trials by managing the timeline, resources, budget, and staff of clinical activities to achieve the study objectives
  • Write clinical protocols and protocol-associated documents including Informed Consent Forms, Clinical Monitoring Plans, and other documents as needed or requested
  • Supervise study team members including Clinical Research Associates and Clinical Trial Assistants
  • Develop study feasibility and cost estimates for outsourced clinical operations activities
  • Interface effectively with other groups within the organization
  • Work closely with Immunology personnel on clinical laboratory activities including specimen management
  • Collaborate with Supply Chain personnel to produce investigational product forecasts and identify distribution, storage, and accountability requirements
  • Collaborate with Finance personnel to provide financial information related to clinical development, including budget forecasts.
  • Participate on core project teams and study teams as needed or requested
  • Ensure appropriate trial operational infrastructure:
  • Assist in developing staff and creating a desirable work environment in order to attract and retain qualified clinical operations professionals
  • Ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
  • Evaluate and implement tools and processes to improve operational efficiency

Technical Skills and Knowledge:

  • Strong communication skills (verbal and written); effective in interaction with senior and junior colleagues
  • Current knowledge of FDA and ICH GCP regulations and guidelines
  • Software knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe Professional
  • Good judgment and problem solving skills
  • Ability to think strategically and tactically in order to prioritize and delegate tasks
  • Entrepreneurial spirit with “can do” attitude and initiative


  • BA/BS degree or higher, preferably in the life sciences
  • Minimum of 7 years prior relevant experience in the pharmaceutical/biotech industry or relevant clinical research organization, with a minimum of 2 years management experience
  • Demonstrated project management/clinical operationsexperience and leadership skills (e.g. managing cross functional study teams, managing outside collaborators)
  • Vaccine clinical trial experience is required
  • Experience with Phase IV trials
  • Needs to have an understanding of the cost of such trials and the challenges associated with them (i.e., patient enrollment).
  • Needs to have opinion on trials costs, and recruitment for ID vaccines e.g. Chikungunya would be a nice to have.