Summary
Overview
Work History
Education
Skills
Timeline
SalesManager

PavalaRoja K

Senior Project Specialist, Centre Of Regulatory Expertise
Hyderabad,TG

Summary

  • Experienced Clinical Research Professional with three years in Regulatory start up activities as Senior clinical Process Associate and had experience in
  • Site contracts end to end process, drafting and sending site close out letter,
  • Participated in proposal meeting, negotiation and management, including monitoring of associated budgets and contracts, discussion with investigators for the contract execution,
  • Escalates appropriately to study questions and issues raised by senior management, investigative sites, vendors, monitors, and consultants.
  • As a Senior Project specialist in Centre Of Regulatory Expertise team,
  • Mentorship to Project specialist during all the phases of project,
  • Responsible for understanding the project scope, cost, setting up the project the activities in Project view, activating the charge code, revenue recognition and billing,

Overview

4
4
years of post-secondary education
5
5
years of professional experience

Work History

Senior Project Specialist

PAREXEL
Bangalore
10.2018 - Current
  • Expereience in Sales Force (contract Link), Oracle Finance Tools (One step Billing, Oracle Project Finance), Market to Order, QuIPS (Quality issue Processing System), Insight Validator (Regulatory publishing tool)
  • Handling Project management end to end services from project initiation, Execution, close out for Integrated product development and Regulatory projects (CMC labeling, Health authority submission and publishing).
  • Responsible for Quality Issue tracking, Quality Metrics, Key Performance Indicators in regulatory services.
  • Worked as Client facing contact for all the projects.
  • Familiar with Finance Tools, Revenue recognition, Invoicing and Billing.
  • Participated in successful client audit and provided project specialist support for the client audits in Bengaluru location.
  • Provides trainings and mentorship to Project specialist during all the phases of project.
  • Handled 22 projects individually within a month of experience.
  • My contribution for one of the high revenues (5 million USD) projects have been recognized at the global level.

Senior Clinical Process Associate

IQVIA
Bangalore
12.2015 - 10.2018
  • Create contracts, accomplish promotion, grant site management access and associate contacts to project site in Clinical Trail Management System (CTMS)
  • Site Contracts:.
  • Worked on Budget Parameters (including Subject Visits, Site Costs, Invoiceable Items, etc.).
  • Worked in amendment, Notice Letter, Assignment and Assumption and handled Site contracts end to end process.
  • Preparation of CRO checklist for all the contracts, tracking of Fully Executed contracts in CTMS, ELVIS upload and notification of payment to Investigator Payment Administration team.
  • Had cross functional team communication for Legal language from the legal team, budget from budget analyst.
  • Supports customization of Global contracts.
  • Budget:.
  • Customization of site budget based on Grant Plan for Low, Medium and High Budget.
  • Responsible for the budget negotiation with the site.
  • Support Regulatory Lead with preparation of Investigational Products label text, adaptation, translation, artwork proof reading and approvals.
  • Contacts, Research facility creation in CTMS.
  • Duplicate check and merging of investigator and research facility in CTMS.
  • Review of Essential Document Packs, eTMF upload of ENF documents, Data entry and Document tracking of essential documents.
  • Tracking of substantial amendments and clinical trial documents at core level.
  • Filing of sponsor contracts such as Confidential Disclosure Agreements and Clinical Trial Agreements in the Sponsor Contract Management system.
  • Recognition received from Sponsor-Partnership team for the good progression in the contracts work.
  • Received 16 Work Worth Doing awards within 2.5 years of service in the organization.
  • Received employee of the month (Nov 2017) for the development of new strategy (IP Labels and site contracts work) to deliver 100 % quality in the stringent timelines.

Education

B.Tech -

ACT Campus, Anna University Chennai
08.2010 - 05.2014

Skills

    Clinical Trial Management system

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Timeline

Senior Project Specialist

PAREXEL
10.2018 - Current

Senior Clinical Process Associate

IQVIA
12.2015 - 10.2018

B.Tech -

ACT Campus, Anna University Chennai
08.2010 - 05.2014

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PavalaRoja KSenior Project Specialist, Centre Of Regulatory Expertise