Summary
Overview
Work History
Education
Skills
Certification
Awards
Timeline
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Saniha Prakash

Clinical Project Coordinator 2
Chikkaballapur

Summary

Enthusiastic and accomplished Clinical Project coordinator with a passion for Clinical Research and Pharmaceutical sciences seeking admission in process validation and regulatory affairs program at Technological University of the Shannon. Eager to leverage my background and participate in the academic community and further develop expertise in regulatory affairs and process validation.

Overview

4
4
years of professional experience
3
3
Certifications

Work History

Lab Centralized Project Coordinator

IQVIA and its Affiliated Companies
10.2020 - Current
  • Supervised 10-15 projects simultaneously from project start through delivery by prioritizing needs and delegating assignments, maintaining project on schedule by managing deadlines and adjusting workflows.
  • Established rapport and engaged with stakeholders to build lasting professional relationships.
  • Mentoring new joiners in the department
  • Archiving reports/documents along with timely updating and maintenance of individual and team trackers
  • Liaising between internal and external departments (Global management, sponsor team, Lab Ops, Specimen Management and trial sites) to assure appropriate process occurring according to schedule and keep the parties updated on project developments.

- Study set up: Uploading details of participating project sites in LIMS database, process portal access, process import permit and coordinate with courier to provide pick-up details etc, to the participating sites.

-Conduct phase: Monitoring on-time release of patient laboratory report including safety and alert reports. Performing monitoring activities for mega trials which includes but is not limited to: monitoring the day to day running of designated projects, including overview of specimen management receipt, lab analyses, and other scope of activities as detailed in the project monitoring plan

-Closeout phase: Resolve all outstanding issues, send out closeout memos to sites, prepare and submit closeout checklist. Participate in data reconciliation as well.

Intern

Ce-Chem
12.2019 - 01.2020
  • Completed research, compiled data, updated spreadsheets, and produced timely reports.
  • Analyzed problems and worked with teams to develop solutions.
  • Interacted with customers by phone, email, or in-person to provide information.
  • Sorted and organized files, spreadsheets, and reports.
  • Trained in tablet, capsule, liquid oral, packing sections and quality control department.

Education

Diploma in Clinical Research Domain -

CLRI
Bangalore
04.2001 -

Bachelor of Pharmacy -

Rajiv Gandhi University Of Health Sciences
Bangalore
04.2001 -

12th Grade- Department of Pre-University Education - Physics, Chemistry, Mathematics And Biology

St Joseph's Convent Girls' PU College
Chikkaballapur
04.2001 -

10th Grade- Karnataka Secondary Education Board -

St Joseph's Convent Girls' High School
04.2001 -

Skills

    Project Management

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Certification

LEAN SIX SIGMA WHITE BELT, 2021, 2021

Awards

  • Spotlight award by IQVIA impact program for team support and collaboration provided during crucial study moment.
  • Ovation award by IQVIA impact program for efforts and contribution provided to meet stringent deadlines and proactively communicating with stakeholders and making a positive impact on the assigned studies.

Timeline

Lab Centralized Project Coordinator

IQVIA and its Affiliated Companies
10.2020 - Current

Intern

Ce-Chem
12.2019 - 01.2020

Diploma in Clinical Research Domain -

CLRI
04.2001 -

Bachelor of Pharmacy -

Rajiv Gandhi University Of Health Sciences
04.2001 -

12th Grade- Department of Pre-University Education - Physics, Chemistry, Mathematics And Biology

St Joseph's Convent Girls' PU College
04.2001 -

10th Grade- Karnataka Secondary Education Board -

St Joseph's Convent Girls' High School
04.2001 -
LEAN SIX SIGMA WHITE BELT, 2021, 2021
LEAN SIX SIGMA YELLOW BELT, 2021, 2021

Good Clinical Practise certification from National Institute on Drug Abuse (NIDA)

Saniha PrakashClinical Project Coordinator 2