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Dr
Karen J Williams, Senior Director of Project Management and Clinical Operations
Dr
Williams has a BSc (Hons)
in biology
and PhD
in bioengineering
both
from
the University
of Strathclyde
in Glasgow,
Scotland. Dr
Williams started
her clinical
research career
as a CRA in a company
specializing
in controlled
release systems
then
moved
to large
pharma
(Boehringer
Mannheim)
where,
for
9 years,
she
had clinical
development
responsibility
for
a variety
of compounds
(oncology,
cardiology,
respiratory,
renal,
and hepatic).
In this
position
she
had responsibility
for
trials in these therapeutic
areas nationally
(UK) and internationally.
Thereafter, Dr
Williams moved
into
the CRO industry
where she managed small CROs for
5 years,
then for
the 7 years
prior to joining
Sticares
InterACT,
she
was a freelance clinical
research consultant taking
on
short and long term contracts.
Dr
Williams spent
2 years
on
a full time contract with
Novartis Oncology
and 4 years
with
Pfizer Oncology
where
she
had responsibility
for
all operational
activities
for
three
oncology
compounds,
one
of which
had an
NDA submitted
in 2011. Dr
Williams has been responsible
for
managing more than
50 oncology
trials over the course
of her career
including
breast,
prostate, ovarian,
non small
cell
lung,
small
cell
lung,
hepatocellular,
renal
cell,
pancreatic,
gastric
and colorectal
cancers,
multiple myeloma,
hypercalcaemia of malignancy
and bone
metastases. Many
of these trials, which
span phases
I - IV, were
global.
Many
of these studies had different components such as multiple
vendors for
monitoring,
data management, central
labs, core labs for ECGs
and/or
imaging.
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