Summary
Overview
Work History
Education
Skills
Work Availability
Quote
Timeline
Generic

Manochandran Selvanayagam

Stevenage

Summary

  • Self-motivated Clinical Data Manager with 6.5 years of experience in data management. Collaborates effectively with multi-functional roles to identify and leverage areas for improvement in data systems. Bringing comprehensive understanding of clinical studies and documentation needs.
  • Adhered to the internal / customer SOPs and kept audit ready at any given point of time during the study.
  • Acted as a liaison between Customer and internal team.
  • Has worked as a lead data manager – planning and managing resources, timelines, quality and key point of contact with customer.
  • Has worked extensively with CDASH, SDTM and Sponsor specific data standards/ guidelines.
  • Trained on GCP, GDPR, 21 CFR part 11
  • Experience in Validation activities – Created PQ and IQ scripts. Performed adhoc testing, dry run and Execution of Qualification scripts (OQ, PQ and IQ).
  • Has performed UAT of eCRF, Edit Checks and User profile testing of clinical systems.
  • Has strong experience in reviewing the CRF Specification and Edit Check Specification. Has successfully handled the EDC system issues.
  • Have created External data transfer specification and performed extensive testing of the external system.
  • Performed (i) the programming and documentation of programs for use in creating statistical tables, listing and figures (ii) the programming of analysis dataset (derived datasets).
  • Have good experience in medical writing. Have written Interim study reports for PAN-India studies.
  • Have good experience in project management activities and people management activities like resourcing, customer communication, issue handling.

Overview

6
6
years of professional experience

Work History

Data Steward

Zifo RnD Solutions
Cambridge
01.2021 - Current
  • Supported establishment, adoption and application of data standards across systems and processes related to product master data.
  • Monitored and managed data cleansing requirements and data conversion initiatives.
  • Developed and maintained product data dictionary to document data source, ownership and accountability details.
  • Worked closely with technology enablement partners to design, create and deploy data management and governance processes.
  • Established and managed key performance indicators to measure and improve processes, systems and data.
  • Mapped data between source systems and warehouses.
  • Developed and modified programs to meet customer requirements.
  • Demonstrated leadership skills in managing projects from concept to completion.

Senior Clinical Data Manager

Zifo RnD Solutions
Chennai
05.2018 - 01.2021
  • Recruited and hired top-performing individuals bringing undeniable experience and wealth of skills to organization.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Participated in committees to discuss electronic health records and methods to improve overall workflows.
  • Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Conducted education and training activities for physicians, nursing staff and administrative personnel.
  • Implemented new coding and billing procedures that helped alleviate number of denied claims from insurance carriers.

Clinical Data Manager

Zifo RnD Solutions
Chennai
09.2016 - 04.2018
  • Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
  • Implemented new coding and billing procedures that helped alleviate number of denied claims from insurance carriers.
  • Created data management plans and provided input on study designs.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Participated in quality assurance reviews to verify accuracy and reliability of data.
  • Identified issues, analyzed information and provided solutions to problems.
  • Managed system for secure storage, transmission and manipulation of clinical data.
  • Upheld critical security standards when managing user access actions such as setting up and removing accounts.
  • Collaborated with medical teams to create uniform standards for clinical data reporting.
  • Built complex data analysis reports and provided timely feedback to stakeholders.
  • Minimized manual system errors with streamlined data entry process.

Education

B.Tech - Chemical Engineering

Kongu Engineering College

Skills

  • Data Governance
  • Data Integrity
  • Information Confidentiality
  • Data Trending
  • Monthly Journal Entries
  • Verbal and Written Communication
  • Exception Reporting
  • Data Validation
  • Safety Reporting
  • Medical Writing
  • Study Design and Conduct
  • People Management
  • Teambuilding
  • MS Office
  • Dependable and Responsible
  • Planning and Coordination
  • Critical Thinking
  • Excellent Communication
  • Decision-Making
  • Training and Development
  • Teamwork and Collaboration
  • Data Entry

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Quote

There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins

Timeline

Data Steward

Zifo RnD Solutions
01.2021 - Current

Senior Clinical Data Manager

Zifo RnD Solutions
05.2018 - 01.2021

Clinical Data Manager

Zifo RnD Solutions
09.2016 - 04.2018

B.Tech - Chemical Engineering

Kongu Engineering College

Similar Profiles

CREATE PROFILE
Manochandran Selvanayagam