Manager, Clinical Operations
- Employer
- PaxVax, Inc.
- Location
- Redwood City, California
- Posted
- Feb 15, 2018
- Discipline
- Clinical, Clinical Development, Clinical Trials
- Required Education
- Bachelors Degree
- Position Type
- Full time
The Manager, Clinical Operations will report to the Senior Director, Clinical Development, and will be responsible for planning Phase I to Phase IV clinical trials of PaxVax's development-stage and licensed vaccines. The Manager, Clinical Operations 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.
Responsibilities:
-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
- Build and maintain relationships with Contract Research Organizations, travel to sites/investigate sites
- 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 with Senior Management to develop and achieve corporate goals within the expected time frames
- Work closely with Biostatistics and Data Management personnel on clinical data activities including case report form design and data cleaning
- 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
Qualifications:
- 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
- Experience building clinical operations groups and associated infrastructure
- Experience managing Clinical Research Associates
- Demonstrated project management/clinical operations experience and leadership skills (e.g. managing cross functional study teams, managing outside collaborators)
- Vaccine clinical trial experience highly desirable
- Medical writing experience (clinical study reports, publications) highly desirable
Travel:
- Domestic and International travel may be necessary