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Job Summary:
The
Manager Clinical Affairs, reporting to
the Chief Technology Officer, will be
responsible for successful execution of
assigned clinical trials within budget
and in conformance with global
regulations and internal policies and
procedures. He/She will perform
development of clinical trial protocols,
final reports, clinical investigator
brochures, negotiation and execution of
investigator agreements.
The
Manager of Clinical Affairs will be
responsible for all aspects related to
international clinical sites and studies
for Company product including
management, monitoring and related field
work for a new medical device of which
is poised to now enter the FDA clinical
trial phase.
Job
Description:
The
Manager Clinical Affairs will perform
all or some of the following Job
description:
-
Gather
scientifically and legally sound data
required for market launch
-
Evaluate
and interpret clinical research data to
ensure timely and accurate data analysis
of completion of interim and final
reports and scientific presentation of
current ongoing and future study data in
a way that fairly and accurately
reflects study results
-
Participate in appropriate in-house
meetings to represent the department and
in operational management activities as
a shareholder of the company.
Minimum Requirements / Knowledge /
Skill For Manager Clinical Affairs Job
-
Five-plus
years of directly related experience in
clinical research (CRA experience
including on-site monitoring) with 2
years management experience
-
Broad,
up-to-date knowledge of medical devices
-
Knowledge
of current government regulations of
clinical research involving devices is
highly desirable including regulations
outside the United States
-
Excellent
analytical and communication skills,
both oral and written, with familiarity
of the technical jargon within the
medical field
-
Good
managerial skills and ability to
interact effectively with subordinates,
management and professionals in the
field
-
Refractive product experience a plus.
Minimum Education Requirements /
Certification / Licensure For
Manager Clinical Affairs Job
-
BA/BS or
equivalent years of experience
-
Advanced
degree preferred.
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