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Re: biopharm post# 212404

Wednesday, 04/01/2015 6:15:42 PM

Wednesday, April 01, 2015 6:15:42 PM

Post# of 345756
Job Posting Update : Peregrine/Avid : 1 added : 25 total now

will update full listings later... see prior post for former 24 jobs and descriptions. This job just posted April 1, 2015 and 1st Project Managment position I've seen with no reporting people. Must be related to all those collaborations past, present and ????

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Clinical Project Manager

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01-Apr-2015 to 30-Jun-2015 (PST)
Clinical OPS
Tustin, CA, USA
Salary
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical project management expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy bavituximab which has been given a fast-track designation by the FDA.

If you meet the following criteria, we encourage you to apply:

SUMMARY

The Project Manager for Clinical Research is responsible for developing project plans and tracking clinical projects. The Project Manager also develops high quality, integrated cross-functional plans for the project/clinical trial. Applies best project management practices in the development, initiation, planning, execution, control, and closing of projects. May also interact with research and development, marketing, manufacturing and regulatory departments as appropriate. Responsible for tracking the efforts for the trial both within the Company and through a variety of vendors.

Note: This role has project management responsibility and no direct reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Review project proposals/plans and evaluate time frame, limitations, and procedures for accomplishing project.
• Document project scope, goals, timelines (including expected completion dates), and deliverables.
• Develop detailed project timelines and associated communications documents.
• Effectively communicate project timelines to project teams and management.
• Meet with project stakeholders on an ongoing basis.
• Prepare project reports for project teams and management.
• Ensure project priorities and key decisions are documented.
• Confer with Clinical Management and Clinical Trial Director/Manager to document project plans and document changes.
• Prepare status reports and modify plans, as required.
• Develop tracking metrics that estimate future project timelines.
• Collaborate with departmental leadership and program staff to prepare project reports and participate in meetings to discuss the status and progress of each project.
• Supports department management by arranging and facilitating meetings, developing agendas, reporting meeting minutes and action item follow up.

QUALIFICATIONS

• Basic qualifications are a four year Bachelor's degree in a scientific discipline with a minimum of 5 years of biotechnology or pharmaceutical industry experience required in a clinical project management role.

• Knowledge of clinical study guidelines, including FDA, ICH and GCP. Familiarity with the drug development process is required.

• Strong computer skills including MS Excel, PowerPoint and MS Project.

• Other requisite skills include attention to detail, the ability to multi-task and prioritize and strong oral and written communication.

• Certificate in Project Management is desirable.

OTHER REQUIREMENTS

Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.


"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline."
-- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!

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