Pritam Hazra

• As a Clinical Operation Manager (COM) Responsible for operation, project management and project delivery within India and Bangladesh region

• Accountable for project finance, budget, quality, timeline and customer relationship

• Responsible for CRA/CTA line management

•Work closely with BD team from RFI to Bid Defense meeting

• Vendor management

• Key working committee member to define RBQM/Centralized monitoring process, policies, system and tool at enterprise level.

• Represent Novotech in key business forum e.g. ISCR

• Accountable for end-to-end Centralized Monitoring (CM) / Risk Based Monitoring (RBM/RBQM) activities for assigned projects e.g. Clinical Operation and Centralized Monitoring plan, Risk Management, Quality Tolerance Limit, UAT, CSR etc.

• Functional management of project resources

• Provide oversight of Project management and clinical operation activities in assigned project

• Clinical Operation oversight to other CRO

• During my tenure with IQVIA, I have served different roles and responsibilities i.e. CTA, e-TMF Lead, Project Management, Centralized Monitoring Lead and Clinical Lead

• Manage project resources (CRAs/ /CTAs/Centralized monitoring team)

•Lead the implementation of Centralized Monitoring/ RBQM at project level

• Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.

• Project schedule and finance management

• Execution of project plans e.g. Clinical operation plan, Project management plan, Risk management plan etc

• Keep a close tab on study and site performance indicators e.g. Site Visit and compliance to monitoring plan, Action Item, Protocol Deviation, SDV, Query, Patient Recruitment, CTMS and TMF

• Attend Kick-Off meetings, ongoing team meetings and client meetings as needed. Management of meeting documentation.
• Start-up, Site management, IP and Vendor management

• Site Management activities at VIMHANS hospital for phase II and Phase III Neurology studies

• Have successfully faced 4 sponsor audits and 1 DCGI inspection

• Site identification, selection, start-up, and site management activities

• Site Management activities at NSCRI hospital for phase II -IV Oncology studies

• Have successfully faced 2 sponsor audits.