Primary Location: USA-North Carolina-Durham
Organization: USA02 - US Clinical Development Svc
Purpose:
Organization: USA02 - US Clinical Development Svc
Purpose:
Responsible for managing
internal and external projects that utilize significant resources from
the R&D (Research and Development) and SBI (Statistics and
Bioinformatics) teams at EA, a Quintiles Company.
Responsibilities:
- Adhere to all EA policies, procedures and employee handbook contents.
- Assist in defining the goals, objectives and scope of projects on an ongoing basis.
- Manage multiple projects from start to finish: develop work/task breakdown structures to define project milestones, timelines, dependencies and resource requirements; continually track progress to anticipate delays and other potential risks in order to recommend dynamic re-allocation of resources; lead communications to keep all project stakeholders informed; develop budgets and track expenses.
- Develop and maintain progress summaries that are accessible to all project stakeholders.
- Lead communications with external clients as needed.
- Where required, provide assistance to lead development scientists to summarize capacity, costs, personnel, equipment, reagents and time requirements for ongoing test procedures and/or technology platforms being developed or implemented.
- Assist in the transition of newly developed test procedures to Laboratory Operations.
- Develop and refine policies and procedures for the development and implementation of new test procedures.
- Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
- Other duties, as assigned.
Required Knowledge, Skills, and Abilities:
- Working knowledge of GLP, CLIA and HIPAA requirements.
- Demonstrated expertise in project management.
- Excellent planning, organizational, customer service and communications skills.
- Expert user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with appropriate tools for managing, visualizing and reporting on projects.
Qualifications
Required Education and Experience:
- BS or BA.
- Minimum five years of experience, with at least two years direct experience in project management.
- Experience with molecular testing in a clinical laboratory operating under GLP and/or CLIA guidelines is preferred.
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