Teva Pharmaceuticals Clinical Research Assoc I BPharm /
MSc
Company Info
Teva is a
global pharmaceutical leader and the world's largest generic medicines
producer, committed to improving health and increasing access to quality health
solutions worldwide. Our employees are at the core of our success, with
colleagues in over 80 countries delivering the world's largest medicine cabinet
to 200 million people every day. We offer a uniquely diverse portfolio of
products and solutions for patients and we've built a promising pipeline
centered around our core therapeutic areas.
We are continually developing patient-centric solutions and
significantly growing both our generic and specialty medicines business through
investment in research and development, marketing, business development and
innovation. This is how we improve health and enable people to live better,
healthier lives. Join us on our journey of growth!
Job
Description
Overseeing
the smooth running of BA/BE studies.
Collecting,
compiling, completing and reviewing data obtained from research.
Informing
participants about study during ICF process.
Get involved
in the Investigational product administration process.
To act as a
custodian and monitoring of research participants to ensure adherence to study
rules.
Adhering to
research regulatory standards and in-house SOPs.
Adhering to
ethical standards like ICH-GCP and GLP.
Maintaining
detailed records of studies as per FDA and other required guidelines, including
things such as drug administration and subject specific case report forms.
Co-ordination
with pathology laboratory regarding screening, post study and follow up sample
analysis.
Participating
in subject enrolment efforts for new BA/BE studies.
Ensuring that
the necessary supplies and equipment for a study are available before
initiation of study.
Engaging with
study staff for timely completion of study documentation to meet stringent
timelines of project submission.
Collects data
as required by the protocol. Assures timely completion of Case Report Forms.
Maintains
study timelines.
Completes
study documentation and maintains study files in accordance with requirements
as per in house SOPs and procedures including, but not limited to, consent
forms, source documentation, case report forms and investigational material
accountability forms (if required).
Engaging with
subjects and understanding their concerns.
Qualifications
3-4yrs years with BPharm / MSc
Function Research
& Development
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