Bhanu Prasad

Project Management analyst, with 8+ years in Clinical Research and 3 years’ experience in Pharma industry. Currently working as Sr. Project Management analyst. Since working as Project Management analyst, I have extended my knowledge and experience in project schedule, risk management, finance, budget, vendor management, change control management, communication with sponsor and other functional leads. I possess rich industry experience on operational aspects of conducting end to end clinical studies i.e., from Start-up phase to study close out including, leading and working as collaborative clinical team to deliver high quality data as per ICH-GCP, SOPs and protocol requirements (late phase /RWE studies).

• ACE Level Award -2 for Client Excellence, ACE Level Award -2 for People Excellence at Covance.
• Bronze award for proactive approach and problem-solving skills on assigned projects., 2023.
• Spotlight award for efforts in leading Wingspan eTMF training session and sharing best practices to team, 2023.
• Ovation award for consistent support in monthly department forum management., 2023

• Senior Centralized Study Specialist, Apr 2018 - Oct 2021, Covance, Bangalore, Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory Green light to a site to start enrolling patients into the clinical trial, Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines, Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines., Checking and validation of Regulatory documents in accordance to Sponsor requirements and country regulations., Follow–ups with Clinical team regarding missing documents or updating of documents to ensure the quality of documents as per Sponsor and Covance SOPs., Preparing and reviewing the Study staff material to conduct the trial before Site Initiation Visit (SIV), Filing of documents as per study guide lines, Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records.
• Allocator, Mailbox work distribution to the team. Allocation of requests on daily basis to the team., Completing the departmental Projects as assigned in accordance with specified timelines., Presentation of updates to the team on monthly basis., Team meetings with regional Local Start up teams., Supervision of workload and deliver the work within Service Level Agreement (SLA)., Monthly work reports submission to Regional Functional Manager
• Team Lead, Ensure project deadlines, commitments, and goals are met by monitoring project’s daily outputs., Perform complex process and task that eventually result in high quality deliverable that are completed according to service legal agreements (SLA’s) and within project timelines., Participate in document management (review, maintenance, storage as applicable)., Perform quality checks (QC) of indexed documents (Site, Country and Core), maintain the accuracy and consistency within e TMF., Coordinating the updates and concerns from the project management team to my Team and Vice-Versa.
• Team member, Review document for its acceptability as per sponsor instructions provided-(Essential Quality Check). Pre-QCed Acceptable document accessed & named as per requirement, Control file (Macros excel sheet) is completed under specific Document subtype folder as per the stringent instructions., Index The Documents as per PSMT (Protocol Specific Matrix Tool)., Following trackers & document required to be referred to index a document DIA, LoEE V13,eCTMS Report, Control File, Lessons Learnt & other sponsor Site Personnel Tracker-Internal, Review QC of the indexed document for acceptance of document updating of trackers., Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures., Sort and classify coded material for filing. Create files according to established classification system., Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information., Coordinate workflow through assignment of tasks and establishment of procedures., File, maintain and process reports, collections, and validations., Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports., Assist in the training of new team members on departmental procedure
• Mentor, Performed mentor activities for Newly Joined to provide oversight of Research activities related to safety submissions and safety documents review, Gave training sessions on the complete processing and reviewing of Safety and regulatory documents.