Job title: Project Specialist - ESR (Externally Sponsored Research)
Hiring Manager: Project Lead – ESR and Grants
Location: Hyderabad
% of travel expected: Travel required as per business need
Job type: Permanent and Full time
About the job
Our Team:
Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main responsibilities:
The SBO ESR project specialist will support the Specialty Care, Vaccines and GenMed GBU with regards to the below activities
Responsible to manage the incoming ESR requests liaising with the medical global and local teams and to ensure ESR are managed as per internal procedures
Responsible for Sponsor/Investigator assessment at study outline review step (sponsor qualification checks).
Act as first recipient of external study proposals submitted in the Sanofi system: evaluate and analyze the request, perform quality checks, identify whether the ESR is a Medical study or an R&D; study, identify the Franchise (if any), identify the reviewers and liaise with them to ensure adequate review of the external study proposal by the appropriate review panel.
Responsible for ESR records / document filing (audits, internal control).
Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system. Liaise with appropriate stakeholders.
Provides Fair Market Value (FMV) review and approval to ensure appropriate evaluation criteria are being utilized to provide appropriate benchmarked compensation when ISS /ESC studies are engaged to provide a service to the Sanofi companies
Provides project management support for CDA creation and management ESR studies
Supports protocol QC activity
Provides ESR QC activiti