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
2018.10 - 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
2015.12 - 2018.10
- 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
2010.08 - 2014.05
Skills
Clinical Trial Management system
Site Contracts and budgets
Investigational Products Labelling
Informed Consent form
Project managementQuality Management
Leadership
Microsoft office software
Clinical Trial Agreement
Confidential Disclosure Agreements
ICH GCP
Salesforce
Timeline
Senior Project Specialist
PAREXEL
2018.10 - Current
Senior Clinical Process Associate
IQVIA
2015.12 - 2018.10
B.Tech -
ACT Campus, Anna University Chennai
2010.08 - 2014.05