Summary
Overview
Work History
Education
Skills
Knowledge Skills Ability
Timeline
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SHWETA KADAM

Kalyan East

Summary

Motivated and dedicated clinical research professional with extensive experience in TMF completeness, Clinical Documents, Processing, Quality Checks, SIL Review, and Metadata action items. Proven track record of successfully driving clinical research projects and contributing to the management of clinical trials as a clinical research coordinator. Collaborative team player focused on achieving project goals.

Overview

5
5
years of professional experience

Work History

TMF Document Specialist

IQVIA RDS PVT LTD
05.2022 - Current


  • Ensure filing clinical trial documents with accuracy and compliance to file plans and SOPs.
  • Ensuring SIL review, Document QC, Indexing, and Metadata AIs.
  • Ensuring project deadlines, commitments and goals are met with Quality.
  • Carrying out spot checks of team members. and Identifying missing documents in TMF.
  • Act as a SME with the record management team.
  • Currently preparing and presenting in Account Refresher training.
  • Served as liaison between Records Management and internal user departments regarding Trial Master File.
  • Applying RM expertise to assist multiple projects and project teams.
  • Sponsor communication, meeting organizer.
  • All documents in ENF Processing Tool to be reviewed, grouped into batches, registered, indexed, QCed according to timelines defined by IQVIA SOP.
  • Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed.
  • Monitoring and assistance in the preparation of closed studies for transfer to clients per agreed due dates.
  • Currently Leading five studies as primary QCer to the sponsors which includes backlog management, resource management, query resolution.

e−TMF Specialist

KlinEra Global Services
06.2021 - 05.2022
  • Technical QC and Approval of Clinical Electronic Submission workflows. To ensure quality and timely clinical trial documentation across the clinical program.
  • Worked in Reclassification and Correspondence Uploading ad hoc project.
  • To support TMF activities in overseeing the quality and integrity of the TMF at a cross functional level to meet regulatory requirements and inspection readiness at all times.
  • Processed and track final essential artifacts required throughout all phases of the study in accordance with Sponsor SOPs, GCP and ICH guidelines.
  • Performed eTMF Reconciliation tasks (Missing document, duplicates identification etc.
  • Maintains the TMF in a state of audit readiness for quality and compliance.
  • Participated in client audits and regulatory inspections by providing guided access to the eTMF study area.
  • Master batch loader preparation, FTP and data migration.
  • Linking of source and translation documents in TMF to identify missing placeholders.
  • Functional quality checks for approved documents.
  • Worked with study teams for rejection and update the require checks.
  • Worked on Quality Issues log and Deletion Requests
  • To check, review and upload documents in Veeva vault and coordinate with the study team for the essential requirements.
  • Ability to set up and update CSF with available document.

Clinical Research Coordinator

Rav Research PVT.LTD(Aims Hospital)
04.2020 - 06.2021
  • Facilitate and coordinate the daily clinical trial activities and plays a critical role in the conduct of the study.
  • Scheduled study subject appointments and serves as the patient liaison to the PI and other participating physicians.
  • Review and comprehend each assigned protocol including study proceedings and timelines. Work closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol.
  • Coordinate and attend sponsor Site Selection visits, Routine monitoring visits, and study close out visits.
  • Complete case report forms. Extracts data from patient file (Source documents) in a timely manner.
  • Respond to data clarification requests in a timely manner.
  • Coordinate with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement.
  • Maintain subject screening logs, enrolment log and protocol deviation logs.
  • Maintain Subject visit Tracker of upcoming visit of all subjects enrolled on clinical trials.
  • Coordinate and facilitate monitoring and auditing visits. Notifies appropriate institutional officials of external audits.
  • Perform specimen processing and shipment of biological specimen duties.
  • Assist with development of study materials including but not limited to, the informed consent document, case report forms (CRFs), electronic data capture software - Oracle, Medidata, Clindox, RDC, onsite, Enrolment logs, and drug/device accountability logs.
  • Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
  • Assist the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement.
  • Handing the feasibility of the incoming new studies of the site from diverse pharmaceuticals and disease profile. Dossier submission to the Ethics Committee (initial and final).
  • Review of eCRP and all ICD documents before SIV procedure.

Education

Post Graduate Diploma -

Clinical Research
03.2021

Bachelor -

Biotechnology
12.2020

Skills

  • Electronic trial master file
  • Good clinical practices
  • Quality control
  • Good planning and time management
  • Ability to establish and maintain effective relationshipss
  • Veeva
  • Wingspan
  • L-eTMF tool

Knowledge Skills Ability

  • Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ALCOA+ standards.
  • GClinical data management
  • Attention and accuracy in work.
  • Ability to work under pressure and strong timelines.
  • Tools Knowledge: Veeva, Wingspan, l-eTMF tool, Phlexglobal, Clindox, Oracle.

Timeline

TMF Document Specialist

IQVIA RDS PVT LTD
05.2022 - Current

e−TMF Specialist

KlinEra Global Services
06.2021 - 05.2022

Clinical Research Coordinator

Rav Research PVT.LTD(Aims Hospital)
04.2020 - 06.2021

Bachelor -

Biotechnology

Post Graduate Diploma -

Clinical Research

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SHWETA KADAM