Associate, Clinical Project Manager

Company: Sun Pharma Advanced Research Company Ltd.
Location: Princeton
Posted on: May 15, 2022

Job Description:

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 development.

The Associate, Clinical Project Manager will be responsible for the following

Responsibilities include:

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 clinical protocols
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.) as applicable
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 training file

Qualifications:
- 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