Study Start Up Lead
Talentmark is recruiting for a Country Study Start Up Lead to join a company in the Pharmaceutical industry, at their site based in Welwyn Garden City, on a contract basis for 6 months.
Salary:
Daily:
£339
- £376.97
PAYE
or
£450
- £500
per
day
Umbrella.
Country Study Lead Role:
1. Drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients.
2. Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
3. Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
4. Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).
Your
Background:
5. Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable
6. Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
7. Strong experience with UK specific clinical start up systems including IRAS, CPMS & iCT and ARSAC
8. Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
9. Experience managing vendor/CRO relationships
10. Experience management site relationships and leading leading site set up through to site activation
Company:
Our
client
is
one
of
the
world's
premier
innovative
biopharmaceutical
companies,
discovering,
developing
and
providing
over
160
different
medicines,
vaccines
and
consumer
healthcare
products
to
help
improve
the
lives
of
millions
of
people
in
the
UK
and
around
the
world
every
year.
Location:
This
role
is
based
at
our
clients
site
in
Welwyn Garden City, for 2 days a week, and there will be some site visits, and home working for the remainder of the week.