Clinical Project Manager

South San Francisco  ‐ Onsite
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Keywords

Description

Responsibilities:

* Manage all Clinical Operational activities associated with assigned studies
* Develop and manage the clinical budgets and timelines
* Manage the CRO and vendor identification and selection process
* Manage the various CROs and vendors involved in the study (e.g. monitoring, data management, central labs, IVRS, etc)
* Lead cross-functional teams
* Manage key study parameters (e.g. start-up activities, drug preparation, enrollment, data collection, etc) and proactively identify solutions when issues arise
* Provide senior management with timely updates on progress, changes in scope, timelines and resources
* Assist operational management team with preparation and implementation of operational procedures/guidelines
* Manage the development process for protocols, amendments, investigational brochures, CRFs and other study-specific documents coordinating input from the various functional teams
* Manage the organization of investigator, steering committee, data monitoring committee meetings, etc.
* Manage all study supply requirements
* Manages CRAs and any assistants assigned to the studies which includes providing guidance, performance development, coaching, and mentoring
* Assess resourcing and work with Associate Director/Director to recruit appropriate candidates

Skills:

* Solid clinical trial management experience. Hands-on experience with several clinical trial components (e.g. monitoring, data management, contracts, report writing, etc.)
* Experience managing a Phase III study; preferred
* Experience leading cross-functional teams
* Experience managing CROs
* Strong project and people management skills
* Energetic, self-starter, able to multi-task and be proactive
* Minimum 6 years experience in the pharmaceutical industry with approximately 2-3 years managing clinical trials
* Ability to work as a team player and the ability to work in a fast-paced environment
* Must be flexible, detail-oriented and have an interest in professional growth
Start date
07/2014
From
Real Staffing
Published at
09.07.2014
Project ID:
738708
Contract type
Freelance
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