Ramya Raj

Experience

• 

  Symbion Pty Ltd

  May 2007 - Jul 2010

  Team Lead

  • Reviewed the data entered by the validator, planning and assigning the review plan to the Validation team.• Forecasted workload and scheduled team to complete within scheduled turnaround time, thereby enhancing efficiency and meeting deadlines.• Set-up targets, monitored overall achievements on a daily, weekly & monthly basis to meet delivery requirements• Set-up and implemented internal reporting system to monitor quality, gave feedback and re-trained staff as required.• Prepared reports with a view to monitor the performance and efficiency of team members, ensuring compliance with pre-set quality parameters.• Created and sustained an environment that fosters development opportunities and motivate high performance resulting in improve efficiencies• Initiated continuous improvement measures for performance of all employees Show less

• 

  Quintiles

  Aug 2010 - May 2015

  Senior Clinical Data Coordinator

  • Served as a Lead Data Operations Coordinator for many protocols with less than 5 operations staff (excludes DE) or had a leadership role in a specific area or process on a large study with guidance• Served in the role of back-up to a Data Team Lead• Conducted data review (SAE, ECG, LAB, IVRS Reconciliations, PD Review, Migration activity and Listing Review)• Wrote and resolved data clarifications• Coordinated a database audit team• Developed and tested databases and edit specifications• Performed User Acceptance Testing of eCRF using HPQC and other tools. • Developed and maintained good communications and working relationships with CDM team.• Successfully managed multiple Database Locks• Conducted basic quality control procedures• Mentored to assist and guided new personnel in the team Chaired cross functional review meetings Show less

• 

  PPD

  May 2015 - Jun 2017

  • Act as the lead data manager for one or more projects and may also provide support to another lead data manager on one or more projects. • Independently and efficiently oversee and/or perform, with quality, all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation within an assigned study. • Mentor junior level staff on all associated tasks within a study. • Liaise with the sponsor and other functional groups as required and communicate with management regarding all data management activities within studies. • Designate tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedure (SOPs) and the DVM. • Represent Clinical Data Management at internal and external meetings and presentations including business development activities.• Responsible for administrative oversight and may provide financial oversight of designated projects. Show less • Act as the lead data manager for one or more projects and may also provide support to another lead data manager on one or more projects. • Independently and efficiently oversee and/or perform, with quality, all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation within an assigned study. • Mentor junior level staff on all associated tasks within a study. • Liaise with the sponsor and other functional groups as required and communicate with management regarding all data management activities within studies. • Designate tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedure (SOPs) and the DVM. • Represent Clinical Data Management at internal and external meetings and presentations including business development activities.• Responsible for administrative oversight and may provide financial oversight of designated projects. Show less

  • Clinical Data Manager II

    Nov 2016 - Jun 2017

  • Clinical Data Manager I

    May 2015 - Oct 2016
• 

  DOCS

  Jul 2017 - Jan 2019

  Lead Data Manager
• 

  Labcorp

  Feb 2019 - Sept 2021

  Associate Manager
• 

  GSK

  Oct 2021 - now

  Manager