Deepthi Nadella
Pflugerville,TX
Summary
Seasoned, innovative, result-driven senior clinical data manager with 8+ years of experience executing clinical research initiatives and projects. Proficient in managing clinical data in phases I-III of trials using Electronic Data Capture (EDC) systems. Skilled at ensuring data integrity, accuracy, and regulatory compliance. Adept at collaborating with cross-functional teams to streamline processes and drive efficiency. Proven track record of delivering high-quality data within strict timelines.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Sr. Clinical Data Manager
Foundation Medicine
01.2021 - Current
- Perform requirements gathering, quality review, generation, and transfer of genomic data for internal cross-functional purposes, clinical trial support, and data delivery
- Oversee and supervise data aspects of Study start up, progress, and close out process and QC transfers
- Execute work with adherence to CLIA, IUO, and state-specific requirements
- Support the development, programming and implementation of Genomic Biomarkers
- Coordinate with internal and external teams (CPL’s, CRO’s, CDOAs,Vendors) for data transfer requirements and QC performing recurring, ad-hoc data transfers, and data reconciliation, IXRS Data Transfers
- Provide input to the software development team to improve processes and technology used to perform data transfers and assist in reconciliation efforts
- Develop work instructions, and/or SOPs and create working groups with different internal teams to fit a constantly evolving pipeline
- Experience working on Biomarkers and programming
- Create DTA to sponsors and various CRO companies and customized the data sets as per their requirements
- Generate and upload ASCII data transmission files according to specifications and worked with clients setting up CDISC and SDTM files
- Assist in data migration technology including CDASH, CDISC, system mapping, and database designs
- Coordinate with CDOAs, CDMs, CPLs on the development, planning, and management of project timelines, study designs, protocol concepts, resolved issues as needed
- Support the management of external vendors and CRO's ensured quality and completeness of study
- Responsible for data management, analysis, and entry on an on-going Data Transfers in real-time basis, development issues resolving of data queries from biopharmaceutical companies
- Troubleshoot programming issues in the database and submitting tickets to next UAT
- Involved in numerous internal and external study audits
- One of the point person for circulating agenda, meeting materials and documenting meeting minutes
- Provide input on quality improvement processes/evaluate barriers and implementing with solutions
- Assist in monitoring the onboarding/training processes for incoming members of the CDM Team
- Implement local Veeva and SharePoint sites to streamline workflows and improve efficiency
- Involved in panel group for interviewing, hiring, onboarding, and training new staff members
Sr. Clinical Data Manager
Medtronic
09.2018 - 03.2020
- Supervised all the Data Management activities internally and coordinated with external vendors
- Developed and reviewed the CRF’s accordingly with the study protocol and applicable SOP’s
- Optimized quality check (QC) of data by manual review to identify any missing, erroneous and implausible data
- Assisted the internal team, CRA’s, and vendors according to project requirements
- Expanded and reviewed study documents like CCG/CCI, DMP and external data reconciliation guidelines
- Generated database specifications including CRF specifications & Edit check specifications (ECS/DVS), and annotation of CRF’s for assigned clinical trials
- Planned and oversaw all data management activities following client requests
- Ensured the data management process follows the study protocol, SOP’s and ICH GCP standards and guidelines
- Developed Data Transfer Agreement’s (DTA’s) and act as point of contact with external data vendors and/or core labs
- Execute UAT and develop Edit checks for different studies
- Document all the Clinical Data Management processes and procedures
- Minimized discrepancies in the data in start-up studies and other ongoing studies
- Updated the data management Standard Operating Procedures (SOP) as needed
- Mentored and upskilled new employees and help them to adhere to the workflow
- Collaborated with External Vendors and Cross Functional Team for internal and external data management activities
- Freeze and locked the data for review, quality checks and then final lock of database
Clinical Data Manager
Syndax Pharmaceuticals
01.2015 - 08.2018
- Executed Data Management activities for clinical trials from Phase I- III
- Developed Test scripts (Dirty and clean data) to perform UAT of edit checks and validation of manual listings
- Developed DMP, DTA’s, CRF Completion Guidelines (CCG/CCI) and other DM-specific documents
- Assisted the internal team, CRA’s, CRO’s and vendors according to project requirements
- Contributed to designing Data Validation Plans including edit checks and manual listings
- Executed UAT and Quality checks of data for several trials
- Accomplished SAE reconciliation, lab reconciliation/external vendor data reconciliation for several clinical trials
- Worked closely with programmers to create, review and validate DVS/ECS (edit check specifications) and query logic
- Performed the close-out activities including the lock of database
- Ensured the compliance of the Data Management processes with the standards (CFR21 Part11)
Education
Advanced Diploma - Dental Hygiene, Dental Hygiene/Hygienist
Cambrian College
01.2015
Bachelor's Degree - Dental Surgery
NTR University of Health Sciences
01.2005
Skills
- Clinical Data Management
- Biomarkers
- Electronic Data Capture (EDC)
- Data Validation
- Therapeutic Areas
- Documentation
- Project Management
- Collaborative Problem Solving
- Attention to Detail
Certification
Data Management for Clinical Research from Vanderbilt University
Awards
Hackathon winner on 2023 - Foundation Medicine
Jul 2023
Dean's Scholar - Cambrian College
Timeline
Sr. Clinical Data Manager
Foundation Medicine
01.2021 - Current
Sr. Clinical Data Manager
Medtronic
09.2018 - 03.2020
Clinical Data Manager
Syndax Pharmaceuticals
01.2015 - 08.2018
Bachelor's Degree - Dental Surgery
NTR University of Health Sciences
Advanced Diploma - Dental Hygiene, Dental Hygiene/Hygienist
Cambrian College
Similar Profiles
Yan ZhangYan Zhang
Software Engineer III at Foundation MedicineSoftware Engineer III at Foundation Medicine
Russell MerulloRussell Merullo
Software Engineer at Foundation MedicineSoftware Engineer at Foundation Medicine
Alissa Kerry-StumpAlissa Kerry-Stump
Sr Director, BioPharma and Corporate Alliances at Foundation MedicineSr Director, BioPharma and Corporate Alliances at Foundation Medicine