Noopur Suba
TMF Review Lead
Ahmedabad
Summary
Overall, 13+ years of experience in Clinical Research. Excellent in applying problem-solving and analytical skills to operational issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). Expert in creating guidance documents, building, and revising the process and continuous reporting to the management to create a quality conscious system. Expert in identifying and assisting in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Team leader with a great commitment in driving the team towards meeting the organizational objectives.
Overview
14
14
years of professional experience
7
7
years of post-secondary education
Work History
TMF Review Lead
Novartis Healthcare Pvt. Ltd
Hyderabad
01.2022 - Current
- Established and Lead team of outsourced partners to ensure delivery of high quality and timely TMF Quality Review of Internal studies
- Identified, planned and drive implementation of business initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis
- Network and leverage expertise to anticipate and identify trial and regional issues, identify areas of process breakdown, assess situations, and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver consistent TMF documentation across clinical trial
- Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in agile way to new or evolving business priorities
- Providing robust oversight of 3rd party vendor activities including monitoring sustainable performance against SLAs
- Embeds risk-based mindset across team and in service delivery, ensuring identification, evaluation, and management of risks, including mitigation activities
- Support department and business teams in preparation for and during audits, inspections, and migration activities
- Owns CAPA(s) arising from inspections/audits ensuring their closure on time.
- Leads team, support recruitment, retains, manages, and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and fosters safe environment for team dialogue and growth
- Set priorities, manage schedules, and develop robust resourcing model to support timely delivery of TMF services
- Lead/contribute to cross functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring deliverables are achieved in line with agreed time frames and budget.
- Resolved problems, improved operations and provided exceptional service
- Demonstrated leadership skills in managing projects from concept to completion
- Demonstrated strong organizational and time management skills while managing multiple projects
- Worked well in team setting, providing support and guidance
- Cultivated interpersonal skills by building positive relationships with others
- Acted as team leader in group projects, delegating tasks and providing feedback
- Demonstrated creativity and resourcefulness through development of innovative solutions
- Adaptable and proficient in learning new concepts quickly and efficiently
- Passionate about learning and committed to continual improvement
- Self-motivated, with strong sense of personal responsibility
- Assisted with day-to-day operations, working efficiently and productively with all team members
- Identified issues, analyzed information and provided solutions to problems
Senior TMF QC Manager/ TMF QC Manager
Novartis Healthcare Pvt. Ltd
Hyderabad
05.2017 - 10.2020
- Responsible for timely assessment of quality and completeness of TMFs for assigned portfolio of studies
- Identified and communicated TMF risks/trends/patterns and worked with key stakeholders to define and implement pragmatic remediation
- Executed vendor oversight plan, monitored service metrics, and identified opportunities for improvement to operating model
- Acted as point of escalation for issues for necessary actions
- Served as Subject Matter Expert on TMF training materials, formal and informal processes, and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key stakeholders
- Provided Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs
- Identified and implemented improvements to document management processes to improve quality of TMFs
- Acted as business lead for innovation projects to enhance TMF quality assessment
- Supported forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects
- Supported refinement of TMF management strategy for assigned portfolio of studies
- Ensured clear expectations for TMF set up and maintenance, including contractual agreement with third parties, for outsourced studies.
Expert Clinical Document Specialist/Sr. Clinical Document Specialist/Clinical Document Specialist
Novartis Healthcare Pvt. Ltd
Hyderabad
07.2013 - 03.2015
- Ensured all assigned operational trial deliverables are met according to timelines, operational procedures, and quality standards
- Acted as SME for specific tasks (like FPP, TMF TOC, CSR Appendices) within Clinical Document Specialist (CDS) group
- Performed HQ TMF TOC, eTMF tracker and CSR Appendices QC activity and shared feedback as appropriate with all relevant stakeholders
- Defined, in collaboration with PCM group, and performed self-inspection plan for HQ Trial Master Files, including sharing feedback and findings with relevant stakeholders
- Performed clinical data review of selected panels for assigned studies under direction of Clinical Trial Head
- Functioned as coach/trainer/on-boarding partner for CDS/Sr CDS as required
- Lead/co-lead several process improvement initiative(s)
- Conducted knowledge/best practice sharing sessions as well as process improvement sessions for group, and documented and implemented action items as appropriate
- Shared best practices or lessons learned within TMF Line Function at various forums
- Assisted CDS Manager in different activities related to CDS group including but not limited to tracking CDS Group metrics, assisting with resource algorithm refinement for CDS group
Project Specialist
INC Research (erstwhile Kendle)
Ahmedabad
06.2010 - 06.2013
- Coordinated planning, scheduling and successful execution of multiple large-scale projects
- Conducted walk-through with clients prior to project close, completing punch lists and answering all questions
- Participated in project budget and cost control measures, tracking progress and making necessary financial adjustments to meet company goals. Effectively managed pending site payments for 290 global sites within a quarter for in-licensed study.
- Monitored project milestones and adjusted scheduling to meet deadlines
- Analyzed project performance data to identify areas of improvement
- Monitored project progress, identified risks and took corrective action as needed
- Developed and implemented project plans and budgets to ensure successful execution
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts
- Maintained open communication by presenting regular updates on project status to customers
- Verified quality of deliverables and conformance to specifications before submitting to clients
- Facilitated workshops to collect project requirements and user feedback
- Reported regularly to managers on project budget, progress and technical problems.
- Deputized PL on several occasion and ensured smooth running of projects and deliverables
- Increased customer satisfaction by 15% by solving problems and concerns effectively.
- Utilized designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries) to provide analysis of information to Project Leader (PL)
Clinical Research Coordinator & Scientific Medical Writer
Retina Foundation and Eye Research Center
Ahmedabad
09.2009 - 05.2010
- Maintained subject files and make available necessary documents for EC submission
- Provided ongoing status reports of site visits to CRA within required time
- Ensured timely and accurate transcription of information on source documents and electronic CRFs
- Maintained Investigational product accountability
- Helped doctors in proof reading and writing research articles at site
- Presented on basics of bio-statistics and how to choose parameters in research so that bio-statistics could be applied correctly while writing paper.
Education
Certified ScrumMaster (CSM) from -
Scrum Alliance
India 02.2023 - 02.2023
Certified Project Management Professional (PMP) from Project -
Project Management Institute
India 12.2020 - 12.2020
Certified, Lean Six Sigma Green Belt -
Novartis
India 03.2017 - 03.2017
MBA - Operations Management
ICFAI University
Hyderabad 07.2015 - 10.2017
PG Diploma - Clinical Research
Institute of Clinical Research, India (ICRI)
India 07.2008 - 06.2009
Bachelor of Pharmacy -
SNDT University
India 06.2004 - 06.2008
Skills
Project Management
Additional Information
- Galaxy team award for contributing towards the Clinical Technology Platform Transformation project to create an end-to-end operating model, Nov 2022
- Star Award for supporting Subway Audit, Sep 2020
- Above & Beyond Award for contribution in “Aavishkaar”, Hyderabad site initiative, Mar 2017
- Winning Team for “Wait, Wait Don’t Tell me yet! The Oncology Quiz – 2015-16.
- Above & Beyond Award for contribution in “Aavishkaar”, Hyderabad site initiative, Feb 2016
- Special award of the year–For the contributions in 2015, CTMR-CDS group.
- Shining Star award – For contribution as scribe for internal assessment in Novartis Oncology, Hyderabad site, 2015
- PQS award – For active contribution in BALANCE initiative, Novartis – Oncology, 2015
- Spot award - For preparing Guidance document for CSR appendices and TMF TOC in CTMR-CDS group, Novartis-Oncology, 2014
- Spot award – For supporting study of colleague with urgent submission requirement in CTMR-CDS group, Novartis-Oncology, 2014
- Received appreciation gift for organizing and successfully managing 5 regional IMs in India at Kendle, 2011
- Awarded with real recognition award while working as Project Specialist at Kendle, 2011.
Publications
· Review article on “Randomization and Randomized Controlled Trial”: International Journal of Pharmaceutical
Sciences Review and Research; Vol. 19(1), Mar Apr 2013, Pg.: 40-46, Noopur Suba, Ashutosh Derashri.
· Article on “Clinical Trials: Meta-Analysis”. Highlights of Ophthalmology; Vol. 37(8), 2009, Pg.: 20 24, Noopur
Suba, Dr. Kamal Nagpal.
· Review article on “Recombinant DNA Technology: Applications in the field of Biotechnology and Crime Sciences”: International Journal of Pharmaceutical Sciences Review and Research; Vol 1(1), Mar Apr 2010, Pg.: 43-49, Noopur Suba, Shivanand Pandey.
· Review article on “Recombinant DNA Technology and Genetic Engineering: A safe and effective meaning for
Production valuable biologicals”: International Journal of Pharmaceutical Sciences Review and Research; Vol
1(1), Mar Apr 2010, Pg.: 14-20, Noopur Suba, Shivanand Pandey.
Timeline
Certified ScrumMaster (CSM) from -
Scrum Alliance
02.2023 - 02.2023
TMF Review Lead
Novartis Healthcare Pvt. Ltd
01.2022 - Current
Certified Project Management Professional (PMP) from Project -
Project Management Institute
12.2020 - 12.2020
Senior TMF QC Manager/ TMF QC Manager
Novartis Healthcare Pvt. Ltd
05.2017 - 10.2020
Certified, Lean Six Sigma Green Belt -
Novartis
03.2017 - 03.2017
MBA - Operations Management
ICFAI University
07.2015 - 10.2017
Expert Clinical Document Specialist/Sr. Clinical Document Specialist/Clinical Document Specialist
Novartis Healthcare Pvt. Ltd
07.2013 - 03.2015
Project Specialist
INC Research (erstwhile Kendle)
06.2010 - 06.2013
Clinical Research Coordinator & Scientific Medical Writer
Retina Foundation and Eye Research Center
09.2009 - 05.2010
PG Diploma - Clinical Research
Institute of Clinical Research, India (ICRI)
07.2008 - 06.2009
Bachelor of Pharmacy -
SNDT University
06.2004 - 06.2008
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