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Description
Company Information:
Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.
Position Summary:
We seek an energetic and results oriented professional to join our oncology clinical operations team.
Duties and Responsibilities:
Manage all clinical operations from on-site monitoring and study management within a matrix environment
Convene and lead a cross functional clinical team
Plan, convene run, and present at investigator meetings
Draft site agreements and budgets
Coordinate and participate in protocol concept, protocol synopsis, template ICF, and final protocol development
Determine patient recruitment strategies and operational feasibility and implementation of clinical trial objectives
Plan and manage study timelines
Develop and review outsourcing specifications for RFPs, vendor, and resource management
Author and refine study monitoring plan
Able to train and provide oversight to a team of CRAs (trip report review, TCR review, co-monitoring, mentoring, etc)
Coordinate ongoing study team review of data
Must be able to manage and communication the operational plan for a given project including timelines, key deliverables, internal and external resources/costs and key data issues
The ideal candidate has to demonstrate strong interpersonal skills, communication skills, writing, project planning, leadership, negotiation and presentation skills, as well as an ability to contribute creative, practical solutions to problems
Conduct on-site monitoring and site management responsibilities for assigned sites
Qualifications:
Strong site management, site monitoring, and clinical operations experience
Strong understanding of the cross functional areas of DM, Biostats, and medical writing
3-5 years of clinical operations experience
Prior clinical operations/site monitoring experience required
Prior CRA oversight responsibilities
Thorough understanding of FDA, GCP, and ICH guidelines
Ability to travel up to 35%
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