PROJECT ASSISTANT

Anju Kumari, B.Ed, M.Sc

EDUCATION

B.Ed. Chemistry and Biology, 2013

Bengaluru University, Karnataka, India

M.Sc. Bioinformatics, 2011

Orissa University of Agriculture and Technology, Bhubaneshwar, Orissa, India

B.Sc. Biotechnology, 2009

Andhra University, Vishakhapatnam, Andhra Pradesh, India

PROFESSIONAL EXPERIENCE

PPD, Bengaluru, Karnataka, India Project Assistant-II Apr 2015- Present

Project Assistant:

Review regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client.

Liaise with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.

Post and distribute CTMS project specific guidance document to project team (if applicable).

Add project team members, global, country and any project level activity plans to project in CTMS.

Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.

Coordination of eTMF/Project file set up.

Upon direction of CTM/PM, finalize the table of content for all study files (Central, Internal, Country, and Investigator), develop and distribute filing guidelines to clinical team.

Perform file reviews and log outstanding issues in project related tracking tools.

Submission of documents to Central and Internal files and update in CTMS.

Develop and maintain assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.

Assist PM/CTM with the creation of study documents, checklists, and reports as needed.

Assist in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc).

Distribute the study Q&A / Directives log to project team and/or notify project team of where updated version can be located.

Create and maintain a Task List for the study and continue to manage progress of the clinical administration deliverables.

Quintiles Research India Pvt Ltd, Bengaluru, Karnataka, India

Clinical Trial Assistant Jan 2014 - Feb 2015

Processed Reimbursement payment to the investigator and sites for study visit forms.

Generated invoices for study visit forms by using EDC (Electronic data capture) System.

Generated quantitative and qualitative periodic update for reimbursement payment by using (Electronic data capture) EDC system.

Coordinated respective study Trial master file document with PEFD (Project email filling database) and PSO (Project support office).

Migration end-to-end of study level data into the Clinical Trial Management System (CTMS).

Facilitated integration of study level data virtually to ensure smooth functioning of clinical systems.

Coordinated with all respective stake holders to ensure timely deliverable of finished serviceable study on clinical system.

Provided quantitative and qualitative periodic updates on progress of integration.

Supported and shared knowledge with study team on specific to obtain valuable information.

On-time query resolution.

LICENSES & CERTIFICATIONS

Diploma in Clinical Research, Clinical Data Management GITS Academy, Bangalore 2013.

PROFESSIONAL DEVELOPMENT

Training while employed at PPD is available upon request.

Diploma Base SAS, GITS Academy, Bangalore 2013.

SAS/Base

SAS/ODS

SAS/Graph

SAS/Macros

SAS/SQL

SAS/STAT

COMPUTER EXPERIENCE

Microsoft Office 2010, Siebel Clinical, Content Server, Adobe Professional, Base SAS programming, Nitro PDF eTMF IWRS.

LANGUAGES

Native Tongue is Hindi; Proficient in English.

Phone number: 973******* / 797-***-****

Email: ac3vxt@r.postjobfree.com / ac3vxt@r.postjobfree.com

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