Summary
Overview
Work History
Education
Skills
Accomplishments
Experience Summary
Timeline
Generic

Rekha Mohan

Bangalore

Summary

A Life Sciences Industry Professional learning Clinical Data Management for over 15 years and now as a Principal Clinical Data Science Lead, exploring opportunities around learning more in the Clinical Space.

Overview

16
16
years of professional experience

Work History

Principal Clinical Data Science Lead

ICON Plc
Bangalore
10.2021 - Current
  • Oversee Data Management Team on a program of studies to ensure all agreed project objectives are met with high level of quality.
  • Manage sponsor relationships through effective project management and communication.
  • Ensure forecasting of study budget and resourcing is accurate on a monthly basis and resourcing requests are raised proactively.
  • Monitor FTE utilization across all assigned studies, set data processing benchmarks and govern team productivity.
  • Drive financials of the study for optimal margins.
  • Prepare DM team for audit readiness and represent DM at internal and external Audits.
  • Demonstrate leadership by consistent delivery and continuous improvement

Senior Clinical Data Lead

Icon Plc
Chennai
04.2020 - 09.2021
  • Closely work with all internal and external stakeholders -Principal Clinical Data Data Science Lead, Statistician, Clinical Trial Managers and Clinicians for timely completion of study milestones and mitigation of risks if any
  • Coordinate with external vendors providing third-party services for managing clinical data.
  • Effectively manage study set up, conduct and close out activities for assigned projects.
  • Manage internal team of Data Managers functionally for day to day activities
  • Assess overall study quality and training needs of study team members on an ongoing basis
  • Key Stakeholder from Icon for Program level Process improvement forums of Sponsor.

Clinical Data Lead

Icon Plc
Chennai
04.2015 - 03.2020
  • Key point of contact for the sponsor and the study team on day to day study activities
  • Handle Kick off meeting for new study set up, CRF specification, DVS, Risk Based Monitoring set up, CRF completion Guidelines
  • Work closely with CRAs, Clinical Trial managers and regional representatives for faster resolution of issues.

Senior Clinical Data Coordinator

Icon Plc
Chennai
10.2013 - 03.2015
  • Take ownership of review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures
  • Perform reconciliations with external data such as Central lab data, PK data, PD data, ECG, SAE and document all the findings as per standard process.

Quality Analyst, Clinical Data Management

Accenture
Chennai
04.2008 - 10.2013
  • Ensures that the audit trails of all reviews are complete and available upon demand
  • Performs as a proactive team member and contributes to quality communications and continuous improvement activities
  • Provide expert comments and feedback on quality initiatives - Assist Team Leads in resolving complex issues
  • Coordinate with Team Leads to identify the patients for which quality checks can be performed.

Education

Master of Science - Biotechnology

University of Madras
Chennai

Skills

  • Clinical Data Management
  • Client Relationship
  • Project Planning
  • Training
  • Team Building
  • Excellent Communication
  • Leadership
  • Teamwork and Collaboration

Accomplishments

  • Handled Clinical Data Mangement of Mega Phase 3 trails with a population of 50000 subjects.
  • Experience in handling Mega Vaccine trials.
  • Expert in managing Cardiovascular, Diabetes and Vaccine trials.

Experience Summary

ICON PLC - Oct 2013 to Current

Accenture - Apr 2008 to Oct 2013

Timeline

Principal Clinical Data Science Lead

ICON Plc
10.2021 - Current

Senior Clinical Data Lead

Icon Plc
04.2020 - 09.2021

Clinical Data Lead

Icon Plc
04.2015 - 03.2020

Senior Clinical Data Coordinator

Icon Plc
10.2013 - 03.2015

Quality Analyst, Clinical Data Management

Accenture
04.2008 - 10.2013

Master of Science - Biotechnology

University of Madras

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Rekha Mohan