Teva Pharmaceuticals Clinic
Subject Care Coordinator I
B. Pharm, M. Pharm or M.Sc
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
To
monitor and perform Quality Check of all study activities from check-in,
dosing, sample collection, processing, segregation, transfer and till checkout.
Co-ordinate
with Project management Group (PMG) for compliance with the sponsor
requirements and timelines.Provide periodic review on status of study files up
to archival of files.
Co-ordinate
with Report Writing Group for the movement of files to the concerned department
and ensuring to maintain timelines.Compilation of study data and review of
clinical reports.
Coordinate
with the Ethics Committee for submission of protocol and other study related
documents.To perform QC of ICF, compensation chart and review of CRF (versus
Protocol), other study related documents prior to EC submission.
To
ensure that all the activities are performed by the delegated staff personnel
in compliance with the EC approved protocol, GCP and relevant SOP’s and
applicable regulatory requirement.
Handling
of monitor’s visits, maintaining of site visit log, resolution of all queries
raised by the monitor/sponsor during his/ her site visit.To carry out other
responsibilities as and when assigned by the management.
Retrospective
review of study documents to ensure adherence to required SOPs and regulatory
requirements. To ensure all appropriate entries after documentation.
Any
discrepencies/ Deviations to be informed to Team Leader and Manager (if
Required).
Ensuring
quality by reviewing all study related documents like Regulatory binder, Raw
data binders, Case Report Form binders, Study close out report, Sample Case
record form, Study updates, screening examination record.
Full
participation in internal and external audits by sponsors and other oversight
entities such as FDA, EU, ANVISA.Review of SDTM & Clinic tables data with
the source document. To verify the calibration and verification of
instruments/equipment.
To
review the execution of Qualification Protocol & Qualification Summary
Report. To prepare & review standard operating procedures as delegated by
PI or HOD or Manager.
Ensuring
quality by reviewing all study related documents like Study Protocol and
amendments, Informed consent form, Clinical Study Report, Electronic Trial
master file, Study synopsis.
Qualifications
B.
Pharm, M. Pharm or M.Sc. (Clinical Research) with 4-6 yrs expereince in
Clinical Quality Control in reputed BA/BE center.
FOR MORE JOB UPDATES
No comments:
Post a Comment