PRADEEPTI REDDY TANDRA (MS Reg. Affairs)

** ******** ******, ******, **- 02115. Phone: 617-***-****. Email:

accfvr@r.postjobfree.com

Summary of Expertise

. Methodological, legislative and ethical understanding of clinical

trials including clinical protocol design, informed consent process,

clinical trial approval. IRB, preparation of study reports, case

reports, monitoring trials, managing clinical data and reporting

adverse events.

. Extensive understanding of clinical trial management execution in

accordance to ICH-GCP guidelines.

. Thorough Understanding of regulatory submissions during biomedical

product development including IRB requirements, compilation and review

process and HIPAA regulations, Sunshine Act.

. In depth knowledge regarding databases like CLinicalTrials.gov, SOP

authoring.

. Technical writing skills required in preparation and maintenance eTMFs

and SOPs.

. Adept at clinical data management and UAT for database maintenance and

tracking.

. Overall knowledge of regulatory authorities like US FDA, EMA, CDSCO

and HC.

. Acquaintance and hands on experience with GXPs and SPL requirements.

. Self-starter with strong communication abilities and team work

experience.

COMPUTER SKILLS

. Adept with MS-Word, Excel, Outlook, Share Point.

. Strong working proficiency with various databases including Oracle,

Inform, Medidata, Rave, KIKA, BioClinica to test for user

adaptability, signature generation and locking as appropriate

. A brief knowledge on submission tool including eCTD, Argus Safety

database and MeDRA.

. Base SAS V. 9.0 certified.

EXPERIENCE

Shire Plc.

Oct 2013- Present

Clinical Operations Specialist

. Assisting with registration and management of Global Clinical

Operations clinical trial information to public websites

(clinicaltrials.gov) including:

o Data entry of updates to be 100% accurate for all Global Clinical

Operations study postings.

o Facilitation of Publication Review Committee and clinical study team

reviews of registration and results data postings

o Coordination of data transfers using validated tool to convert results

datasets into an XML file used to electronically batch load clinical

trial results data to clinicaltrials.gov website

o Perform manual data entry as necessary

. Assisting with coordinating revision and review of clinical operations

SOPs for biennial reviews

. Generation of 1772s, documentation of site visits and site audit

reports.

. Uploading documents into SharePoint site and internal EDMS.

. Preparation, planning and maintenance of study level TMFs. Data QC and

analysis of TMF.

. Vendor oversight.

. Special projects as requested.

Angiographic Core Laboratory, BIDMC, Boston

Jul 2013- Oct 2013

Clinical Research (Compliance Manager)

. Providing regulatory guidance to teams tasked with maintenance of

business projects involving high-risk coronary and peripheral stents.

. Maintenance and updates to cluster sections of eTMFs/TMF designs.

. Updating training records, performing quality checks, internal

documentation practices to comply with internal and external audits.

. Generation and maintenance of tracking reports, study timeline review

and maintenance.

. Ensuring 21 CFR part 11 compliance. Database locking as appropriate.

. Assisted in CRF design, database development, database QC and UAT for

various platforms including Oracle.

. Generation and maintenance of QC reports and assisting in planning and

documentation of CAPA.

. Performing quality checks on internal and external study database to

ensure compliance with protocol requirements.

. Coordinating high-level meetings and team representation at sponsor

meetings.

. Assisted in CRF development, authoring of SOPs and data management

plans.

. Documentation of training records and over-reading financial invoices.

. Assisted in protocol training and guidance regarding updated HIPAA and

GCP practices.

Angiographic Core Laboratory, BIDMC, Boston

Sep 2012- Dec 2012

Clinical Research Assistant

. Disseminating trial reports to Clinical Research Scientists CRSs

/central Clinical Trial Leaders cCTLs

. Documentation of internal and external audit reports. Report

generation and tracking of study progress to document and facilitate

assembly and maintenance of trial data as per departmental SOPs.

. Data entry into electronic Clinical Trial Management systems.

. Management, maintenance and archiving of study eTMFs and paper TMFs.

. Assisted in eTMF document submissions, review and follow-up with site

administrators and PIs.

. Report generation, tracking and routing study progress to various

CROs, vendors, investigators and other stakeholders.

. Validation of internal documentation and documentation of study

records.

. Updating study-specific GCPs as per revised protocols and

documentation of training records.

. Assisted in invoice preparation and financial billing activities and

other administrative activities including site coordination, CDAs,

strategizing agendas and meeting minutes.

. Assisted in database development and User Adaptability Testing.

Dr. Reddy's Labs Limited

Trainee in Formulation Research and Development Department

May 2009- July 2010

. Validation and calibration of analytical equipment. Performed various

formulation operations involved in the manufacture of solid dosage

forms according to the company's SOPs.

. Assisted in log maintenance and documentation control.

. Assisted in compilation work, maintenance and updating of records

according to company's SOPs.

. Conducted dissolution studies for enteric release solid dosage forms.

. Assisted in documentation of batch records

.

EDUCATION

Northeastern University

Master of Science in Regulatory Affairs for Drugs, Medical Devices and

Biologics Apr 11-Apr 13

Osmania University

Bachelors in Pharmacy

Sep 06- Aug

10

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