CURRICULUM VITAE

Name:

Shobana Sundaram

DCRI Position Title:

Clinical Data Specialist III

FG or KRP:

Technology & Data Solutions

Summary of Experience

Twenty years of experience as a data specialist in clinical and scientific research. Managed the data management activities of multiple international trials in several different therapeutic areas. Independent thinker and very good problem-solver.

Therapeutic Experience

Orthopedic Implants (Knee and Hip replacements)

Cardiology (Aortic aneurysms, Atrial Fibrillation)

Health Dermatology (Submental fullness)

Ophthalmology (IOLs)

Infectious diseases

Employment History

Clinical Data Specialist III, Data Solutions, DCRI (CRO) 11/2022 – 11/2023

Oversees project data management processes and activities as Associate Project Leader; facilitates creation and timely delivery of all data management deliverables within the scope of work

Oversees design, development and validation of EDC system (as Lead Data Manager) with input and collaboration from project stakeholders; drafts specifications for electronic Case Report Forms (eCRFs), data validation checks, external data integrations, project data status reports and data review listings.

Develops and maintains project documentation, including project profile, Data Management Plan (DMP), specifications, testing, project-specific work instructions and training, ensuring audit-readiness and DCRI SOP, ICH and 21CFR compliance at all times.

Coordinates with cross-functional team members, sponsor and vendors to reach agreement on project data format, deliverable schedules, disposition, and archival.

Reviewed protocols and provided feedback on Data Management sections

Prepared descriptions of work and budgets for changes to Scope of Work

Programs Used: Rave, IBM Zelta eClinical OS, RedCAp, Medrio, Confluence, Jira, Microsoft Project/Excel, Word

Consultant, Clinical Data Associate/Specialist, Conformis 6/2022 – Present

Manage, Analyze and generated Reports of EDC data for 8 studies involving the various Conformis personalized Knee and Hip implants.

Remote Data management for closing-out studies and working with monitors for minimizing gaps and integrity of data entry.

Generation of Regulatory Reports for the 8 studies.

Obtained Data-Backup DVDs for the 8 studies for Compliance and Regulatory On-site and Remote storage

Programs Used: eClinicalWorks, Medrio, Microsoft Excel, VB, SAS

Clinical Data Associate, Conformis 10/2018 – 09/2021

Trained people on EDC system (Medrio) and designed database for pilot project using Medrio and eClinical OS.

Participated in training for hybrid role including site management responsibilities along with data management

Independently planned and managed data management activities based on project contracts and sponsor communication for paper and EDC trials

Reviewed protocols and provided feedback on Data Management sections

Prepared descriptions of work and budgets for changes to Scope of Work

Oversaw, managed and was accountable to the Project Lead for data management

deliverables, timeline and budget

Oversaw access to data systems on projects, including account management

Participated in department and organizational initiatives including review and maintenance of SOPs

Developed SQL ad-hoc reports for internal and external use, including single row functions, multi row functions, nesting and complex joins

Worked with external parties to agree on data transfer format, contents and schedule.

NGO(www.maithricharity.org) (Content Developer and Designer) 08/2017 – 04/2018

oDeveloped content and designed web pages

Endologix Inc. (Clinical Data Specialist - Consultant) 11/2015 – 04/2017

oSupported data cleaning activities for 3 studies involving fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal aortic aneurysms

oReconciled data transfer GAPs between OracleClinical RDC, Clindatrix, databases with that in eclinicalOS edc

oEnsure data transfer completeness, consistency of data, raised queries, and reviewed responses, and closed queries, SDV'ed data through remote monitoring

oTrack progress ensuring projects meet timelines and quality expectations

oHelped in UAT (User Acceptance Testing)

oProvided status updates to project team / project manager

oHelped study PMs and site monitors in pre-site monitoring visit, close-out site visits preparations

oAcquired specific clinical and therapeutic knowledge related to Endologix studies and products

oReview Adverse Events (AE), and Serious Adverse Events (SAE)

oAssured compliance to the study protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP)

oEliminated unnecessary personnel resources by diligent project planning and saved ~ $200K annually.

Skills/Programs Used: Merge eclinicalOS, OracleClinical, Clindatrix, Data Management, SAS

Kythera Biopharmaceuticals (Sr. Data Steward - Consultant) 10/2014 – 11/2015

oManaged data using Veeva database and Salesforce Customer Relationship Management (CRM)

oPrepared reports and identified data quality issues and discrepancies

oPerformed Data conversion and definition activities and prepared reports on daily basis.

oDeveloped clear data sets to enable a standardized collection and integration

oAnalyzed massive amounts of cross-boundary data content with high level of accuracy

Skills/Programs Used: Data Management, Veeva CRM, Microsoft Excel

Taaratech LLC (Data Manager - Consultant) 10/2013- 08/2014

oHands-on experience on data extraction, transformation, loading with various data sources.

Virginia Commonwealth Univ.- School of Medicine(Instructor) 06/2009-05/2013

oTeaching Instructor of Physiology laboratory course for under-graduate students: pre-med, allied health professionals and nursing.

oPerformed software installation, upgrades/patches, troubleshooting, and maintenance of systems

oWritten technical reports and created/maintained in-house chemical databases.

Corning Incorporated (Sr. Development Scientist – Consultant) 10/2005 –12/2008

oDeveloped and validated source codes to perform multi-scale modeling and simulations

oModeled and simulated network traffic characteristics for wireless Local Area Network

oUsed Advance statistical methods to parse and analyze simulated data

oDeveloped Factory Acceptance Tests for Corning’s High Throughput Bio-system.

oDeveloped Biochemical Assay for protein binding studies using Corning’s HTS- Epic system.

Weill Cornell Medical College, New York, NY (Instructor) 07/2001 – 05/2005

oAided clinical track professors in early clinical and regulatory affairs

oInstructor in Dept. of Physiology using Computational modeling and electrophysiology to study protein folding of small channel protein, Gramicidin

oInstructor for small group conferences and Bioinformatic to medical students

oInstructor of Boot-Camp study for Bioinformatics for medical students in the Tri-State area.

oPerformed software installation, upgrades, troubleshooting, and maintenance of servers

Skills/Programs Used: Fortran, pClamp, Origin, Excel, PowerPoint, Designer, CHARMm

Academic Research 10/1995 – 06/2001

Research Fellow, Dept. of Physiology, Weill Cornell Medical College, New York, NY (10/1995–06/2001)

Research Fellow, Dept. of Physics and Chemistry, Université de Montreal, Montreal, Canada (07/1995–09/1995)

Research Fellow, Dept. of Physics, Royal Institute of Technology, Stockholm, Sweden (01/ 1995–06/1995)

Educational background

oPh.D. in Bio-Physics (Indian Institute of Science, Bangalore, India), 1994

oMS in Bio-Physics (University of Madras, Chennai, India), 1987

oBS in Physics with Mathematics and Chemistry (University of Madras, Chennai, India), 1985

Honors & Awards

oJames R. Houghton Challenger Award for Innovation Teams “Optical Picocell” – (Corning Cable Systems / Science & Technology). Team Member from S&T, Corning Inc., Oct 2006

oInvited speaker in CECAM workshop Lyon, France., Jun 2000

oWinston Fellow, Norman and Rosita Winston Foundation Fellowship in Biomedical Research, Cornell University Medical College, Jul1995 - Jun1997.

Licenses & Certifications & Publications(Recent):

oClinical Data Management (CDM) Online CourseUdemyIssued Nov 2022 · No Expiration DateIssued Nov 2022 · No Expiration Date

oCertificate Course in Clinical Research Certificate Course in Clinical Research

Udemy Issued Oct 2022 · No Expiration Date

oIntermediate Python for Data Science course

DataCamp Credential ID $6,363,601

oIntermediate Python for Data Science course

DataCamp Credential ID $6,363,601

oIntermediate R course

DataCamp Credential ID 4311052

oIntroduction to SQL for Data Science Course

DataCamp Credential ID #6,314,023

oStatistical Thinking in Python ( Part 1)

DataCamp Credential ID #6371283

oSide-chain interactions in the regulatory domain of human glutamate dehydrogenase determine basal activity and regulation

Journal of Neurochemistry · Jan 26, 2015

Mastorodemos, Konstantinos Kanavouras, Shobana Sundaram, Maria Providaki, Zoe Petraki, Michael Kokkinidis, Ioannis Zaganas, Diomedes E. Logothetis, Andreas Plaitakis

Shobana Sundaram 10-Jan-2023

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