Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
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Krishna Gandhi

Decatur,United States

Summary

Dedicated, motivated and detail-oriented Clinical Researcher with years of experience leading and assisting different studies under various therapeutic indications like Oncology, Psychiatry, Cardiology, Immunology, and Major Depressive Disorder. Proven knowledge to absorb and apply new concepts with minimal oversight and a high level of professional integrity. Highly skilled at taking on multiple tasks and prioritizing accordingly. Works independently to produce high quality results and enjoy contributing meaningfully in team environments. Has complete knowledge on processes pertaining to conduct the study.

Overview

12
12
years of professional experience

Work History

CLINICAL TRIAL MANAGER

ICON PLC
04.2022 - 10.2023
  • Ensures that all clinical tasks meet client and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable Standard Operating Procedures (SOPs) and applicable regulatory requirements.
  • Provides timely status reports for the clinical activities on assigned projects.
  • Sets, tracks, and reviews milestones, tasks, timelines and projected hours for all the clinical
    activities for assigned projects, ensuring adherence to contract and budget.
  • Reviews and approves monitoring reports and ensures tracking of ongoing issues.
  • Page 2 Review Essential Documents to ensure sponsor and investigator obligations are being met and
    are in compliance with applicable local regulatory requirements and ICH guidelines.
  • Provides data as required for clinical operations performance and project status metrics.
  • Participates in Investigator meetings, assisting with presentations as needed.
  • Contributes to Business Development Activities participating in proposals and bid defenses as
    needed. Addresses and resolves all internal and external clinical issues for client research
    projects.
  • Recommends and implements enhancements to clinical systems.
  • Interacts with client(s), vendors and PRA functional areas as primary project contact for clinical
    issues.
  • Identifies out of scope tasks from clinical team and escalates to the Project Manager.
  • Liaises with Clinical Operations Managers to resolve resource and performance issues.
  • Leads clinical operations team on a project, providing study specific and therapeutic training
    and mentoring as required.

STUDY MANAGER

TRIO
03.2021 - 04.2022
  • Reviews and approves the monitoring reports and ensure any issue (PDs/non PDs) detected are tracked in CTMS and is followed up till closure.
  • Mentored junior staff members, contributing to their professional growth and enhancing team performance overall.
  • Oversees the activities of the Third Party Organizations (TPO) as applicable and organize teleconferences with them to follow up for the activities they perform.
  • Participated in quality assurance reviews to verify accuracy and reliability of data.
  • Negotiate amendments to financial agreements with site as per trial requirement. Review or approve invoices, support finance with site fee reconciliation.
  • Replies to audit finding if he or she is responsible or act as audit coordinator to consolidate all the
    answers from in the audit report.

DATA VALIDATION SPECIALIST

TRIO
01.2020 - 03.2021
  • Review data pertaining to sites/patients and track the progress of the review either directly in the
    clinical database or in dedicated trackers.
  • Generate queries in the clinical database in case of missing, potentially incorrect and/or inconsistent
    data.
  • Review queries answered by the sites and close them.
  • Verify if confirmed protocol deviations are entered in the RAVE and if not, enter them.
  • Contact CRAs as needed in case of specific issues.
  • Contribute to the development or the review of trial documents associated with data validation
    activities (e.g. data validation written instructions, validation tools specifications, annotated
    validation tools, reports).
  • Lead the ECG reconciliation process to ensure all missing ECG are correctly entered in d

START UP SPECIALIST

TRIO
09.2019 - 01.2020
  • Compile, track, and review essential documents to activate a site (e.g. Site Activation Package).
  • Implementation of site identification and selection activities.
  • Identify. obtain, approve, and file the essential documents that are required for activation.
  • Request and confirm access to study systems (e.g. IWRS, eCRF) for site staff.
  • Compile and track CSU team, I Third Parties Organization (TPO) study specific documents (e.g. training evidence).

ADMINISTRATIVE PROJECT COORDINATOR

TRIO
04.2018 - 09.2019
  • Review, validate, track, and file the essential documents for the participating sites after they have been handed over by CSU team. Follow-ups and tracking missing/incomplete/invalid documents in
    project related systems.
  • Provide administrative support to the project team in study -related activities.
  • Participate in preparation of regular reports and newsletters.
  • Validate invoices according to contract specifications and requests for the corresponding payment to
    be performed.

PROJECT COORDINATOR II

PRA HEALTHSCIENCES
06.2017 - 01.2018
  • Work with the Project Manager and core study team to ensure that project deliverables are completed in accordance with contract and client expectations.
  • Prepared meeting agendas and minutes for distribution and record keeping.
  • Coordinated cross-functional teams to achieve seamless collaboration in achieving project objectives.
  • Provided input and feedback on departmental initiatives, directives and strategies to contribute to project success.
  • Manage site supplies/printed study materials and coordinating timely distribution.
  • Facilitate internal and external system accesses for study participants.
  • Assist with TMF maintenance and ongoing Quality Control.

CLINICAL PROJECT SPECIALIST

QUINTILES RESEARCH PVT LTD
11.2015 - 06.2016
  • Perform complex processes and tasks that eventually result in high quality deliverables that are
    completed according to service level agreements and within project timelines.
  • Create and maintain relevant project documents/ trackers.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines
    and project plans with project specific information.
  • Oversee and participate in document management (creation, review, maintenance, storage, as
    applicable).
  • Act as point of contact for assigned deliverables for specific customers or projects. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

SR CLINICAL PROJECT COORDINATOR

QUINTILES RESEARCH PVT LTD
07.2014 - 11.2015
  • Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
  • Develop study management plans, together with team assignments and accountabilities and oversight
    of database maintenance.
  • Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
    Identify quality issues within the study to implement appropriate corrective action plans. Escalate
    findings and action plans to appropriate parties.
  • Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing,
    and interpretation of financial figures which may lead to identification of out of scope activities not
    previously reported.
  • Prepare and distribute status, tracking and project finance reports, and assist the Project Manager(s)
    with budget allocation and approval of invoices.
  • Maintain out of scope work; ensure backlog variance is not more than +/- 5%; assist in periodic review of
    accuracy of files to ensure audit readiness.
  • Vendor Management

SR CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
02.2014 - 07.2014
  • Prepare and manage study supplies, liaise with third party vendors, coordinate with CRA and CTA team for Asia Pacific region to ensure periodic review of study files for accuracy and completeness.
  • To develop strategies to boost recruitment at sites. Conduct periodic recruitment calls with Principal
    Investigator and team to meet recruitment goals.
  • Prepare Newsletter (Site and CRA) every 7 to 14 days (share important study updates or information,
    sharing recruitment status and recruitment goals for the month, recruitment reminder).
  • Ensure timely submission of EC documents, overlook on EC submission of SUSARs and SAEs with in
    stipulated timelines by site personnel.
  • Manage preparation of upcoming audit documents from CRA/CTA and to provide the same to Sponsor in
    defined timelines.


CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
04.2012 - 01.2014
  • Ensure timely SUSAR distributions for all the sites in the study within the specified timelines
  • Updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Provide administrative support to clinical trials under the direction of the line manager, clinical team
    leads and/or other clinical team members. Activities include maintaining clinical systems, maintaining
    monitoring files in house, TC minutes preparations for the regional team call and coordinated for archival activity.
  • Periodic review and updating of monitoring files in house for its accuracy and completeness

INTERN CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
10.2011 - 04.2012
  • Act as a central contact for the clinical team for designated project communications, correspondence
    and associated documentation.
  • Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required
    training and with required approval.
  • To perform assigned administrative tasks to support team members with clinical trial execution

Education

PGDCM - Clinical Research

JAIPUR NATIONAL UNIVERSITY
India
01.2012

ENGINEERING (BE) - Biotechnology

THE OXFORD COLLEGE OF ENGINEERING
India
06.2009

Skills

  • Trial management

  • Good Clinical Practices

  • Data Management

  • Customer Focus

  • Clinical Trial Oversight

  • Documentation requirements

  • Training and mentoring

  • Clinical Data Management

  • GCP Knowledge

Accomplishments

  • Recognition for successful leading database lock for complex trial.
  • Won several accomplishments for team work and data management.

Languages

English
Full Professional
Gujarati
Native or Bilingual
Hindi
Native or Bilingual

Timeline

CLINICAL TRIAL MANAGER

ICON PLC
04.2022 - 10.2023

STUDY MANAGER

TRIO
03.2021 - 04.2022

DATA VALIDATION SPECIALIST

TRIO
01.2020 - 03.2021

START UP SPECIALIST

TRIO
09.2019 - 01.2020

ADMINISTRATIVE PROJECT COORDINATOR

TRIO
04.2018 - 09.2019

PROJECT COORDINATOR II

PRA HEALTHSCIENCES
06.2017 - 01.2018

CLINICAL PROJECT SPECIALIST

QUINTILES RESEARCH PVT LTD
11.2015 - 06.2016

SR CLINICAL PROJECT COORDINATOR

QUINTILES RESEARCH PVT LTD
07.2014 - 11.2015

SR CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
02.2014 - 07.2014

CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
04.2012 - 01.2014

INTERN CLINICAL TRIAL ASSISTANT

QUINTILES RESEARCH PVT LTD
10.2011 - 04.2012

PGDCM - Clinical Research

JAIPUR NATIONAL UNIVERSITY

ENGINEERING (BE) - Biotechnology

THE OXFORD COLLEGE OF ENGINEERING

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Krishna Gandhi