Summary
Overview
Work History
Education
Skills
Timeline
Generic

Keerthi Kedasu

Lincoln,California

Summary

Dedicated and focused project specialist with Over 7 years of experience in clinical trial project management, excelling at prioritizing, completing multiple tasks simultaneously and following through, to achieve project goals. Flexible, detail-oriented, and adaptive team player with expertise in Clinical Research Project management, staff training and development, and process improvements. Focused and enthusiastic with expertise in Imaging data management, effective processes and procedures.

Overview

11
11
years of professional experience

Work History

Project Specialist, PROJECT MANAGEMENT

PAREXEL International ltd.
05.2018 - 07.2019
  • Preparing the monthly finance reporting to Project managers and develops the invoice billing
  • Also assisted the Project managers with reconciliation and identification of budget forecast
  • Involved in client calls, face to face client audits
  • Prepared meeting minutes and agenda for the client calls
  • Project Planning: Define project scope and responsible for the successful initiation, planning, design, execution, monitoring, controlling and closure of a project in conjunction with timelines, resources and budget
  • Risk Management: Identify and analyze the project risks, mitigating as necessary and making sure to include in the risk communication plan
  • Prepares position-related weekly/monthly reports, develops tables and queries when obtaining statistical information related to clinical research reports
  • Supports the Project Manager in study delivery and ensures the specified quality standards, within timelines and budget
  • Have experience in resource management and effective transitions by collaboration with appropriate Project managers and Line managers
  • Actively involved in the interim analyses, database locks, final exports and study closures
  • Make sure that the study documentation is updated, filed in eTMF and audit ready
  • Make sure study start up, conduct and close out activities are updated all along, in CTMS
  • Collaborates with management to resolve technical/study concerns and problems
  • Review and assist the team in understanding study-related documents like protocols, Informed consent forms, Case Report Form (eCRFs), and other relevant study plans and charters
  • Reviews study specific documents to assist the study team in the appropriate implementation of clinical operations and to ensure accurate data collection and recording
  • Coordinates the initiation and implementation of assigned Projects and work on data reconciliation from the data received from clients
  • Coordinates and directs the appropriate and timely imaging QC and reads for assigned clinical trials
  • Identifies issues and and set up study specific meetings with investigator sites or CRAs & sponsors for issue/query resolution
  • Author documentation pertaining to Standard Operating Procedures (SOPs) as well as project specific procedures including Core Imaging Lab Manual and Site Manual
  • Actively involve in the interim analyses, database locks, final exports and study closures
  • Monitoring within assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocol compliance
  • Perform quality assurance checks on study images
  • Communicates effectively, verbally and in writing, with all internal and external customers (physicians, investigators, study coordinators, coworkers, etc.)
  • Responsible for achieving team targets set by the Line manager / Project Manager and communicating team progress to PM
  • Responsible for facilitating team communication across all locations
  • Collaborates with management to identify resources have the needed skill set and reports the study needs
  • Assist with managing team members work schedule
  • Guides, supports, and leads the project team in carrying out assigned day-to-day tasks.

SENIOR IMAGING RESEARCH ASSOCIATE

Parexel
08.2015 - 05.2018
  • Provide input on new image processing techniques and modalities
  • Take lead role in training and mentoring of Imaging Research Associates and Imaging Assistants (with an emphasis on new hires)
  • Take lead role in training and testing independent reviewers
  • Perform (preliminary) analysis on medical images for a clinical trial
  • Assist independent reviewer during the review process
  • Act as an Associate Project Manager under the guidance of a Program Director or experienced Project Manager
  • Author documentation pertaining to Standard Operating Procedures (SOPs) as well as project specific procedures including Core Imaging Lab Manual and Site Manual
  • Monitoring within assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocol compliance
  • Provide imaging technical expertise to project teams conducting clinical trials that rely upon the results of medical imaging studies
  • Perform random audit checks of study files and imaging processing
  • Perform PM responsibilities and client communication as requested by PM or PD
  • Perform other duties as required by the position.

IMAGING RESEARCH ASSOCIATE

Parexel
12.2009 - 12.2011
  • Ensure the site personnel have a good understanding of the requirements of the study working with investigator sites on site surveys and site qualification
  • Perform image processing (including the downloading of imaging data from media, digitizing, conversion to DICOM format, data entry, region of interest measurements, preliminary review of measurements, video system specific processing) across multiple modalities (including but not limited to X-Ray, CT, MRI, PET, Echocardiography, Ultrasound) using Alice, as well as other third-party software's
  • Perform quality assurance checks on study images
  • Validate and maintain imaging database including images and tracking and review results for assigned projects
  • Querying and following up with sites to resolve imaging issues
  • Maintaining spreadsheets pertaining to the project work assignment
  • Mentor and assist in training of internal personnel
  • Monitoring within assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocol compliance
  • Assist independent reviewers on PAREXEL procedures and policies.

IMAGING Assistant

Parexel
05.2008 - 12.2009
  • Work with Investigator Site on Site Surveys and Site Qualification
  • Ensure completed study start up packages and requested supplies are sent in a timely manner
  • Maintain completeness and accuracy of image tracking study and databases
  • Resolve project related problems and escalate issues that cannot be resolved to the appropriate party
  • Perform image processing (including the downloading of imaging data from media, digitizing, converting to DICOM format, data entry, region of interest measurements, preliminary review of measurements, video system specific processing) across multiple modalities (including but not limited to X-Ray, CT, MRI, PET, Ultrasound, DXA) using Alice, as well as other third party softwares
  • Maintaining central files for Image data/Image Transmittal form/Site correspondence ensuring all files are up to date and accurate
  • Performing various administrative tasks including, but not limited to data entry, site communication, and filing.

Education

Skills

  • Project management experience
  • Clinical data management experience
  • Efficient in MS-Office tools ie MS-word, MS-excel, Power point
  • Documentation and reporting
  • Data review
  • Base SAS (Statistical Analysis system)
  • Client focused approach to work
  • Time and Schedule management
  • Training and mentoring
  • Process improvements
  • Attentiveness and Quick learner
  • Strong analytical and organizational skills
  • Multitasker
  • Problem Solving
  • Work well under pressure

Timeline

Project Specialist, PROJECT MANAGEMENT

PAREXEL International ltd.
05.2018 - 07.2019

SENIOR IMAGING RESEARCH ASSOCIATE

Parexel
08.2015 - 05.2018

IMAGING RESEARCH ASSOCIATE

Parexel
12.2009 - 12.2011

IMAGING Assistant

Parexel
05.2008 - 12.2009

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Keerthi Kedasu