Associate, Clinical Project Manager
Company: Sun Pharma Advanced Research Company Ltd.
Posted on: May 15, 2022
Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical
research and drug discovery organization that was formed in 2007
when SUN Pharmaceutical Industries Ltd separated out its active
projects in drug discovery and innovation into a new company to
provide the focus and the opportunity for growth of these projects
which are now at different stages of preclinical and clinical
The Associate, Clinical Project Manager will be responsible for the
Assist the Project Lead in oversight and management of operational
aspects of phase I-IV US based and/or global clinical trials
Act as primary point of contact for all clinical site management
and oversight activities in accordance to SOPs/procedures
Perform monitoring visit site report review
Assist the team to ensure audit readiness at the site level
Supervise activities to ensure site adherence to appropriate
Ensure proper transmission of clinical data/electronic system
queries to sites, answer questions and obtain alterations to
queries as appropriate
Act as contact for clinical trial supplies and other suppliers
(vendors) as assigned
Assist in the oversight of study start up activities of CROs (e.g.
Site identification, Feasibility, Site selection, Contract
negotiation and Clinical Study Agreement finalization,
Translations, EC and Regulatory submission, Site initiation etc.)
Co-ordinate finalization of IP label & requisition, forecasting of
IP requirements, etc.
Prepare/Review study plans for in-house/outsourced studies. Train
study team on trial documents, processes & assigned SOPs.
Meet investigators and key opinion leaders for assigned trials
Provide oversight of timely updates to Trial Master File & Site
Master Files (TMF/eTMF)
Review of study specific documents including status reports, site
visit reports & study plans (i.e. Protocol Deviations, Data entry &
SDV status, Query status) to ensure quality
Perform Oversight, Co-monitoring and vendor oversight visits to
ensure quality of trial conduct
Contribute to development & finalization of key study documents
(i.e. protocol, Investigator brochure, informed consent document,
case reports form etc.)
Ensure in-house trial closure after completion of all planned
activities and oversee archival of all study documents.
Complete assigned trainings & establish, maintain updated personal
- Minimum Bachelor's degree in a related field
- Minimum 2 to 3 years of clinical trial experience
Disclaimer: The preceding job description has been designed to
indicate the general nature and level of work performed by employee
within this classification. It is not designed to contain or be
interpreted as a comprehensive inventory of all duties,
responsibilities, and qualifications required of employees as
assigned to this job. Nothing herein shall preclude the employer
from changing these duties from time to time and assigning
comparable duties or other duties commensurate with the experience
and background of incumbent(s).
Keywords: Sun Pharma Advanced Research Company Ltd., Trenton , Associate, Clinical Project Manager, Healthcare , Princeton, New Jersey
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