the smart solution for San Francisco jobs

Manager, Clinical Operations

Company: PaxVax, Inc.
Location: Redwood City
Posted on: March 14, 2018

Job Description:

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

Keywords: PaxVax, Inc., San Francisco, Manager, Clinical Operations, Executive, Redwood City, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Technical Software Manager (Library Software)
Description: This position location is at our Emeryville, CA office. Innovative Interfaces Inc. is dedicated to providing leading technology solutions software and services that empower Libraries and enrich their (more...)
Company: Innovative Interfaces, Inc
Location: Emeryville
Posted on: 03/24/2018

Assistant Store Manager
Description: When our pets inspire us every day, it's important to make sure they have everything they need, right when they need
Company: PetSmart
Location: San Francisco
Posted on: 03/24/2018

Bakery Manager
Description: Job DescriptionPOSITION SUMMARYThe Bakery Manager is responsible for ensuring a phenomenal experience for customers in the Bakery area through leading product and service selection, high product quality, (more...)
Company: Sacramento Natural Foods Coop
Location: Sacramento
Posted on: 03/24/2018

VP of Customer Service
Description: THE JOB Actively serve as a key member of the executive leadership team Provide dynamic, visible, and inspirational leadership to deliver strong business results Develop an effective and adaptable support (more...)
Company: Apparel & Fashion Products, San Francisco, CA
Location: San Francisco
Posted on: 03/24/2018

Events Manager - Oakland Marriott City Center (18000RR3)
Description: Heres To Your Journey with Marriott Hotels Resorts Suites At Sheraton, we go above and beyond in everything we do. We are inspired by our guests and one another and are driven to make things better. (more...)
Company: Marriott International
Location: San Francisco
Posted on: 03/24/2018

Associate Director of Developmet, Health and Social Sciences
Description: The Associate Director of Development for the College of Health Social Sciences is responsible for prospect identification,
Company: San Francisco State
Location: San Francisco
Posted on: 03/24/2018

Content Marketing Manager
Description: Were on a mission to help people who work for themselves be more productive and successful. Were looking for an ambitious, passionate and creative Content Marketing Manager to own the creation and distribution (more...)
Company: Stride Health
Location: San Francisco
Posted on: 03/24/2018

VP of Marketing
Description: We are looking for an enthusiastic, analytical and creative Vice President of Marketing to lead all marketing efforts at Company and build a team to support those efforts. From
Company: Entertainment / Broadcasting, San Francisco, CA
Location: San Francisco
Posted on: 03/24/2018

Interventional Pain Management Opportunity An Hour From Sacramento, CA
Description: Anesthesiology opening in Sacramento, California. This and other physician jobs brought to you by Great opportunity for a BC/BE Pain Management Physician to join an established practice an (more...)
Company: All Star Recruiting
Location: Sacramento
Posted on: 03/24/2018

Description: Who We Are br br River City Medical Group br RCMG is a progressive Independent Physician Association IPA of over 700 br physicians uniquely dedicated to serving over 170,000 members within (more...)
Company: River City Medical Group
Location: Sacramento
Posted on: 03/24/2018

Log In or Create An Account


Forgot password?

Find us on Facebook

Find us on LinkedIn

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds