[Employment] Clinical Project Manager, Salix Pharmaceuticals, NC

[Number Crunchers' Web Center]

Clinical Project Manager
Location:  North Carolina
Category:  Research and Development/Clinical

Overview:
The Clinical Project Manager is responsible for providing operational
support for the delivery of assigned studies or programs on time and
within budget. Primary responsibilities include coordinating and
supervising operational aspects of a clinical study, providing
guidance for other study team members and collaborating with the
Clinical Development team in the overall study management by
monitoring deliverables, schedules, timelines and external team
resources. The Clinical Project Manager contributes to the design and
development of CRFs, Informed Consents, specific protocol sections
(i.e. treatment of subjects and study procedures) and the Data
Management Plan. Other responsibilities include coordinating the
collection of clinical data and the development of study related
documents (monitoring guidelines, source document templates,
monitoring visit report templates and other site tools). The Clinical
Project Manager will also conduct co-monitoring for site evaluations,
initiations, monitoring and closeout visits. The selected candidate
will assume a leadership role to ensure the operational milestones and
timelines are achieved. 20 percent travel is required.

Responsibilities / Qualifications:
We seek a candidate with a BS or BA in a relevant scientific
discipline and a minimum of 5 years direct CRA experience in the
pharmaceutical industry or equivalent. The successful candidate must
have the ability to develop tools and processes that increase measured
efficiencies of the project, experience mentoring and developing
junior staff, excellent interpersonal skills and a demonstrated
ability to lead. Working knowledge and experience with Word,
PowerPoint and Excel is required as well as excellent verbal, written
and presentation skills. Candidates must possess a working knowledge
and understanding of FDA and/or EMEA Regulations, ICH Guidelines and
good clinical practices (GCPs) governing the conduct of clinical
trial.

To apply: http://www.ncwebcenter.com/job0813salix.html#clinical