Giridhar Madhusudhan
Mississauga,Canada
Summary
Project management professional with track record of delivering high-impact projects in diverse environments with over 6 years of experience in ophthalmology as a CRM and over 11 years in clinical operations in lead roles. Adept at driving project timelines and ensuring quality outcomes through strategic planning and execution by developing fit-for-purpose trackers and effectively working with a variety of vendors. Highly collaborative, adaptable, and committed to team success and all-stakeholder satisfaction.
Overview
14
14
years of professional experience
Work History
Project Manager
ICON, formerly PRA Health Sciences
09.2021 - Current
- Led Clinical Trial Team (CTT) and Clinical Research Manager (CRM) Country calls and captured meeting minutes and distributed action items for follow up.
- Captured all study-related issues in a storyboard along with the SM and documented them in RIM.
- Created a new fit-for-purpose lab specimen tracker for tracking all lab specimens throughout the duration of the trial before the establishment of LabMatrix.
- Authored, maintained and finalized all versions of the site management plan for the study on IntelliNotion.
- Led the clean-up and reconciliation of all responses from CRMs on the CSR appendices for DBL by capturing, tracking and following-through to completion on all details in the Orbit report - including any changes/updates from the transition from Spectrum to Veeva Clinical and documenting any manual changes on the Orbit report that cannot be captured in Veeva Clinical in an entry in RIM.
- Managed the TMF filing for all clinical scientist and study manager documents and ensured that EDL items are attested in a timely manner and all of this was captured in RIM every 180 days.
- Reconciled imaging data queries between EDC and vendor on a weekly basis and during DBL by coordinating with CRMs/CRAs/Clinical Imaging Scientist.
- Led the inspection readiness efforts to ensure that the MK8591A-053 study team was ready for regulatory inspection
- Developed an entire new lab specimen tracker, in the absence of any pre-existing SOP; wherein all lab specimens were tracked for timely submission and receipt and ensured any missing lab specimens were pro-actively followed-up for submission. Resulting in reduced clinical scientist follow-up requirements and ensured that all samples were received by the study team for DBL.
- Conducted regular team meetings to assess progress, address challenges, and drive accountability, especially for TMF completeness and attestations.
- Provided overall study level status update reports/emails for CRMs on a weekly basis.
- Planned and tracked clinical supplies during start up in its entirety.
- Supported study wherein responsibilities include tracking study timelines, protocol amendment training completion and implementation.
- Mentored junior project managers, enhancing team capabilities and knowledge transfer.
Clinical Operations Lead
HOFFMANN-LA ROCHE LIMITED
07.2021 - 09.2021
- Responsible for the management of quality, operations and technical issues for over 80 sites in three studies and ensured that all data points and images were submitted by sites in time as part of the imaging squad.
- Primary point of contact for CRAs working as site managers to escalate issues of quality and provided oversight as part of the study team to ensure smooth running of three studies.
- Managed three vendors, including imaging and central labs, and liaised with project managers of these vendors to resolve site issues.
- Completed study closure for a Phase 2 pediatric nephrology study a month ahead of schedule.
- Ensured imaging submission delays are reduced by over 50% by developing a dashboard system for tracking of image submission status in real time with the vendor.
- Started up over 120 sites in a month ahead of schedule and ensured that recruitment for two Phase 3 studies were completed a month before expected enrollment closure.
Country Study Specialist
HOFFMANN-LA ROCHE LIMITED
11.2015 - 07.2021
- Managed over 300 sites in over 6 studies in ophthalmology in start-up, maintenance and close out involving all imaging, lab and payment vendors and in resolving any issues escalated from sites.
- Managed and developed processes for the unblinded/unmasked aspect of the Phase 3 double-blinded clinical trial program for over 200 sites ensuring drug is dispatched on-time, authorizing site drug destruction, ensuring site processes in place for managing and monitoring temperature excursions and integrity of IMP management with proper GCP standards at sites in coordination with clinical site monitors.
- Managed Imaging Squad as a process work owner to ensure efficient reconciliation of images from three studies in ophthalmology from over 400 sites and developed vendor metrics for accountability and efficient vendor management.
- Managed the complete closedown of over 300 sites in US and Canada for the Lampalizumab program by coordinating with site staff and clinical site monitors.
- Setup Unblinded and Double-blinded processes for over 4 studies and ensured that all sites start-up well before 2 months of timelines and worked to reduce any masking errors to nil over the course of two years of managing these trials.
- Managed an Imaging Squad and ensured delays and errors in site submissions of images are reduced to less than 2 images per month across 80 sites and ensured these lessons are adapted for all ophthalmology studies.
- Managed and led study-wide initiative in ensuring 10% inclusive/diverse patient populations including elderly African-American, vulnerable minority and pediatric patients in the ophthalmology study.
- Completed enrollment for US sites and database closure one month ahead of schedule for the Phase 2 Pediatric Nephropathy study.
Market Research Analyst
HOFFMANN-LA ROCHE LIMITED
05.2014 - 11.2015
- Executed and managed surveys for assessing sales rep feedback of learning outcomes and of divisional events and analyzed to present trends in assessed metrics of satisfaction to brand teams and customer experience managers.
- Managed survey feedback for Medical education events across all of Roche’s brands to identify and prepared a report of learning outcomes assessments for the Medical Education Manager.
- Analyzed the journey of patients of different diseases through the healthcare system and part of a patient insights taskforce that works to determine gaps that help Roche’s brands.
- Delivered just-in-time analysis and reports for successful brand planning for and launch of Zelboraf and Cotellic.
Study Delivery Coordinator
AstraZeneca Canada
03.2014 - 05.2014
- Was a single point of contact and responsible for managing clinical study sites by collecting for regulatory documents and approving them for patient enrolment.
- Managed clinical databases to update patient enrolment and manage prioritization of study supply shipments.
- Started up over 20 sites for the Phase 3 Olaparib program in under 3 weeks.
Market Research Analyst, Orthopaedics/Dental and Aesthetics
Decision Resources Group
07.2013 - 03.2014
- Forecasted and modelled unit sales and pricing trends in the US and EU markets for different product segments in orthopedics – trauma devices, large joint reconstruction and hip and knee implants – and facial injectables and dental aesthetics.
- Conducted Secondary Market Research to understand important growth and limiting factors to be included in formulated market device model.
- Contacted KOLs and area experts to determine pricing trends and surgeon preference for different product segments.
- Simulated data scenarios and modeled different trends for product segments based on growth factor and proprietary dynamic growth models to account for different variables.
- Prepared custom consulting reports that demonstrate competitive insights for specific product segments in the emerging markets (BRIC, Eastern Europe, Latin America).
- Authored and Published competitive insights and a comprehensive market research report of the Orthopedic Trauma Device market in the United States in 2013 by analyzing each product segment and provided a ten-year forecast of growth trends and price estimates.
- Authored and Published competitive insights and a comprehensive market research report of the aesthetic facial injectables market in the European Union in 2013 by analyzing each product segment by country and provided a ten-year forecast of growth trends and price estimates for the 5 major national markets and 10 supplemental countries.
Associate Study Manager
GLAXOSMITHKLINE
01.2012 - 06.2013
- Managed two clinical studies in HIV and Malaria by working in a cross-functional, global team to deliver clinical study results from active clinical sites.
- Monitored Subject study visits by working with an external vendor to ensure subject compliance through the distribution of gas cards.
- Created a Survey in a cross-functional, global team to ascertain site feasibility for enrollment into trial to be distributed across the globe.
- Created and Maintained Team site for Malaria team project to help in cross-functional collaboration.
- Monitored distribution of supplies of investigational products to clinical study sites on RAMOS by coordinating with local clinical regional managers.
- Assisted writing a key asset clinical development protocol and parts of the informed consent form for a malaria clinical study by working with study managers.
Protocol Therapeutic Experience
Ophthalmology - 6 years
- Diabetic Neuropathy - 4 years - in Adult and Pediatric Populations - Biologic and Device - Hoffmann La Roche
- Geographic Atrophy - 2 years - Primarily in Adult, Elderly Population - Biologic - Hoffmann La Roche
Infectious Diseases - 5 years
- HIV - 4 years - in Adult Populations - Biologic - Merck
- Malaria - 1 year - Anti-Parasitic Biologic - GlaxoSmithKline
Oncology - 2 months
- Ovarian Cancer - Solid Tumor in Adult Populations - Biologic - Hoffmann La Roche
Vendor Experience
Central Imaging Services - Duke Imaging, Clario Imaging
Central Lab Services - Covance/LabCorp, PPD, IQVIA
IRB - Advarra, WIRB
IXRS - Bracket/Signant Health, Almac
Patient Recruitment Services - Drug Dev Limited
Translation Services - Advarra Translation Services
Systems Experience
CDMS (Paper) - ClinTrial, Oracle Clinical
Clinical Trial Management Systems - IMPACT CTMS, Oracle Siebel Clinical (CTMS), Veeva Clinical
EDC - Datalabs, InForm, Medidata RAVE
IVRS/IWRS/RTSM - Almac, Bracket, Signant
Laboratory System - LabCorp Xcellerate,
eTMF - Documentum eTMF, NextDocs eTMF, Veeva Vault eTMF
Programming Languages - Visual basic
Risk Based Monitoring Software - Medidata RAVE RBM
Authoring Software - Intellinotion
Drug Type Experience
Biologic (Ophthalmology, Oncology and Infectious Diseases)
Device (Ophthalmology)
Education
Graduate, Masters in Biotechnology, Jun 2013
University of Toronto at Mississauga, Mississauga, Ontario, Canada
Undergraduate, Biotechnology, Jun 2011
University of Toronto at Mississauga, Mississauga, Ontario, Canada
Languages
English
Native or Bilingual
Tamil
Native or Bilingual
Portuguese
Professional Working
Hindi
Limited Working
French
Elementary
Publications
US Orthopedic Trauma Devices 2014 , Giridhar Madhusudhan, Madhusudhan, Giridhar, 2014, US Orthopedic Trauma Devices 2014, July 2014, 275 pages, 2014
EU Facial Injectables 2014, Giridhar Madhusudhan, Madhusudhan, Giridhar, 2014, European Markets for Facial Injectables 2014, November 2014, 300 pages, 2014
Timeline
Project Manager
ICON, formerly PRA Health Sciences
09.2021 - Current
Clinical Operations Lead
HOFFMANN-LA ROCHE LIMITED
07.2021 - 09.2021
Country Study Specialist
HOFFMANN-LA ROCHE LIMITED
11.2015 - 07.2021
Market Research Analyst
HOFFMANN-LA ROCHE LIMITED
05.2014 - 11.2015
Study Delivery Coordinator
AstraZeneca Canada
03.2014 - 05.2014
Market Research Analyst, Orthopaedics/Dental and Aesthetics
Decision Resources Group
07.2013 - 03.2014
Associate Study Manager
GLAXOSMITHKLINE
01.2012 - 06.2013