PRADEEPTI REDDY TANDRA (MS Reg. Affairs)
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
. 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
. Technical writing skills required in preparation and maintenance eTMFs
. Adept at clinical data management and UAT for database maintenance and
. Overall knowledge of regulatory authorities like US FDA, EMA, CDSCO
. Acquaintance and hands on experience with GXPs and SPL requirements.
. Self-starter with strong communication abilities and team work
. 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.
Oct 2013- Present
Clinical Operations Specialist
. Assisting with registration and management of Global Clinical
Operations clinical trial information to public websites
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
. 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
. 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
. Assisted in CRF development, authoring of SOPs and data management
. Documentation of training records and over-reading financial invoices.
. Assisted in protocol training and guidance regarding updated HIPAA and
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
. 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
Master of Science in Regulatory Affairs for Drugs, Medical Devices and
Biologics Apr 11-Apr 13
Bachelors in Pharmacy
Sep 06- Aug