• Hyderabad Area, India, IN

Revendra Varada

Work History

Work History
Nov 2013 - Present

Data Analyst

Serves as the Trial Data Manager on all projects and works with the Project Leads, the Lead Data Managers and the Country heads to ensure that the project is delivered on time, with high quality standards.

  • Coordinates and leads the data managers for assigned studies and ensures appropriate allocation and track of assigned work.
  • Closely works with the Lead Data Manager, Trial Statisticians, CPO heads globally within and across the process to support and ensure the flexible delivery of assigned tasks.
  • Ensures high quality, timely communication and trial information(resources, status of assigned activities, issues) flow to, Project Leads and Team Manager.
  • Ensure timely, efficient high quality Data Management deliverable's for trials within the process.
  • Provide input, review, and maintenance to global working practices and standards.
  • Ensure Audit readiness for all trials assigned.
  • Identify and plan training needs of the assigned team members.
  • Coordinate with the LDMs and DM team to track, report status and progress of data management for allocated trials and be proactive to ensure smooth and successful achievement of key milestones.
  • Provide inputs to ensure consistency and accuracy of Protocol, Data Handling Plan & eCRFs for assigned trials.
  • Perform trial start up activities, including testing and UAT of Database, edit check specifications, Export and Import programs for assigned trials.
  • Coordinate with Coders, Developers, Third Party Coordinators to ensure that the project timelines and deliverable are met consistently.
  • Perform QC as required and monitor efficiency trends and opportunities for
  • improvements Assist and guide team members in study conduct and close out activities
  • like query management.
  • Track study specific metrics and SLA.
  • Train study team as on when required.
  • Closely works with process management team in development of SOP, SWP's..
Oct 2011 - Oct 2013

Jr Data Analyst

  • Develop and test databases and edit specifications.
  • Understand and comply with core operating procedures and working instructions.
  • Develop and maintain good communications and working relationships with CDM and supporting teams.
  • Plans the necessary activities to achieve milestones and deliverable's according to the project plan.
  • Manages proactively any obstacles that can result in delay of a milestone or missing a deliverable.
  • Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.
  • Identify and report protocol violations Manual and Patient Profile review, issue queries.
  • Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
  • Liaise with 3rd party vendors to clean data.
  • Conducts lesson learned after every milestone achieved.
  • Provide data management or technical support to the project team members as appropriate.
  • Provides input on resource allocation on the respective projects.
May 2011 - Sep 2011

pCRF Designer

  • Worked on trials of low to moderate complexity and with supervision of mentor or a pCRF Coordinator while adhering to all relevant GCP guidelines and pCRF process.
  • Designed Patient Diaries; formatted Patient reported outcomes (Questionnaires) for various trials.
  • Trained and Lead pCRF team of 8 with utmost quality.
  • Closely worked with print shops and external vendors to printing and shipment of trial documents to sites across the globe.

Research Associate

  • Worked closely with directors and other doctors in set-up of Clinical Research Units at CRIUM, Hyderabad.
  • Assisted in writing protocols.
  • Involved in developing SOP and other process related documents

Education

Education

Cranfield University

Jun 2008 - Jun 2010

M.Sc Clinical Research

ICRI, Bangalore

Jun 2008 - Jun 2009

PG Diploma in Clinical Research Management

MNR Degree College (Osmania University)

Jun 2005 - Jun 2008

B.Sc (Microbiology-Genetics-Chemistry)

Sri Chaitanya Jr College

Jun 2003 - Jun 2005

Intermediate (Biology-Physics-Chemistry)

ZP Boys High School

Jun 2002 - Jun 2003

SSC

Skills

Skills
CRF Desinging
Designed CRFs, PROs and Patient diaries for around 150+ protocols.
Clinical Data Management
Worked on various studies as TDM from study start-up to close-out.
SOP Development
MS Excel, PowerPoint
Had extensive knowledge on using MS Excel and PowerPoint as a supporting tool for performing DM tasks.
Adobe In-Design CS 6.0
Used this tool as a main tool for designing CRFs, and other supporting documents

Personal Details

Permanent Address:

Flat # 206, Sokeo Towers,
KPHB V Phase, Opp Reliance Trends,
Kukatpally, Hyderabad, Telangana - 500072

Languages known: English, Hindi, Telugu

Interests: Leadership & Management, Innovation, Strategic Management, Ethical Business, Travel and Exploring new places, Cricket, Chess