Associate Manager, Clinical Development
Location: North Carolina
Category: Research and Development/Clinical
Overview:
The Associate Manager, Clinical Development is responsible for all day-
to-day aspects of clinical trials including clinical development,
vendor selection and management, coordination and management of data
collection, site management and other responsibilities, as required.
The Associate Manager, Clinical Development oversees the scientific
aspects of clinical studies throughout the duration of the study. The
selected candidate provides leadership and therapeutic expertise for
the successful management of clinical trials and must adhere to strict
regulatory requirements of study conduct and industry standards of
Good Clinical Practice. The Associate Manager prepares study
protocols, amendments, specific sections of study manuals/Investigator
meeting notebooks and other documents as needed. Other primary
responsibilities include contribution to the design and development of
CRFs, Data Management Manuals and Data Analysis Plans as well as
preparation and/or review of data listings, summary tables, study
results, manuscripts and scientific presentations, regulatory
documents, IND annual reports, IND safety reports, Investigator
Brochures and NDAs. With direction, the Associate Manager, Clinical
Development also addresses questions regarding scientific and related
procedural issues from Investigators.
Responsibilities / Qualifications:
We seek candidates with an advanced degree and at least 5 years of
pharmaceutical industry experience or a Bachelor's degree in a
scientific discipline and at least 8 years of pharmaceutical industry
experience (clinic setting experience not included). Work experience
must include at least one of the following: Protocol/Amendment
writing, NDA submission experience, CSR writing, data listings review
and abstract/publications writing. Experience must include vendor
management and multiphase clinical trials (I-III). GI trial experience
is preferred. Excellent verbal and written communication skills and
interpersonal skills are required to maintain working relationship
with team members to ensure scientific integrity of clinical studies.
To apply: http://www.ncwebcenter.com/job0813salix.html#associate
