Manager, Clinical Operations

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POST DATE 8/20/2016
END DATE 11/13/2016

PaxVax, Inc. Redwood City, CA

Company
PaxVax, Inc.
Job Classification
Full Time
Company Ref #
360273
AJE Ref #
575939340
Location
Redwood City, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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The Manager, Clinical Operations will be responsible for the planning and efficient conduct of the clinical operations of the vaccine research and development programs. The Manager provides leadership and supervision for the Clinical Research Associates and Clinical Program Managers, and serves as a technical and scientific resource in the conduct of Phase I to Phase IV Clinical Trials.

Responsibilities:
Clinical trial execution and oversight
o Oversee tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities
o Oversee and maintain the relationship with Contract Research Organizations and investigative sites. Typically travels to field sites to supervise and coordinate clinical studies
o Write clinical operation sections of regulatory documents including protocols, Investigator Brochures, IND annual reports, and others as needed or requested
o Develop study feasibility and cost estimates for outsourced work
o Analysis of protocol to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements and IP labeling requirements
Ensure appropriate trial operational infrastructure
o Partner with supervisor to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
o Ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
o Evaluate and analyze tools and processes to support outsourcing efforts
o Work with Clinical Operations team to identify and develop efficient systems for enhancing department efficiency
o Direct process for prequalification of vendors; Request for Proposal (RFP) processes and policies
Interface effectively with other groups within the organization
o Maintain a high level of professional expertise through familiarity with clinical literature and close interaction with Research and Laboratory groups
o Work with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames
o Participate on project teams and study teams as needed or requested
o Act as key resource to provide financial information related to clinical development (study budget forecast and management).
o Collaborate with legal department to develop improvements to document templates, standard processes and tools