Summary
Overview
Work History
Education
Skills
Accomplishments
Software
Timeline
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Nilesh Kakde

Nilesh Kakde

Product Owner, Business Analyst, CDM, Life Science

Summary

Working as a Product Owner and SME for life science analytics and SDQ (Smart Data Query) product.11 years of Clinical Research Domain experience in handling multiple engagements in various capacities which includes Product Implementation, Product Owner, Project Data Coordinator, Clinical Data Analyst and Clinical Research Operation. Experienced in setup, conduct and close out studies in all three Phases of clinical trials. Worked on all phase of Clinical Trials Phase I, Phase II, Phase III on different therapeutic areas such as Respiratory, Cardiovascular, Oncology and Infectious Diseases, Dermatology. Helped business owners translate and implement real-world needs into practical needs, Experience in Project implementation/management and Operations along with Service Delivery Actively involved in client collaboration and trainings and process improvement.

Overview

12
12
years of professional experience

Work History

Product Manager

Saama Technology
Pune
05.2022 - Current
  • Gathering technical and functional client requirements to build product for business need
  • Managing product for different clinical research organizations/Sponsors by developing and accommodating the needs of the Clinical trials within the product communication with cross functional teams with upcoming updates
  • Help with Data consolidation and management of clinical trial data to fit the analytical needs of the research organization
  • Do thorough data profiling based on study documents such as aCRF and Study Protocol received from sponsor
  • Raise data concerns to sponsor if any, for the USDM requirements
  • Creating DTA (Data transfer agreement) for EDC data files, Flat filesetc
  • Creation of Data Quality (DQ) rules and source to target mapping (sttm) documents like USDM
  • Creation of URS documents for custom KPI's
  • Schedule demonstration of the product with customer
  • Act as a SME for Life science and clinical research domain providing training to the IT developers and assisting Development team for understanding of logic provided in USDM for further mapping
  • Assist QA team for the understanding of logic from functional perspective
  • Data analysis and review of the client source documents and database for the development of dashboards, quality analysis and UAT of the developed products
  • Data validation of the different data layers like source (using my SQL in DBbearver), cqs for data integrity, proper data exporting, transfer and loading of data and visualization platform
  • To do sanity (validation) of dashboards from UI front and raising product bugs or mapping issues, if any to the respective teams
  • Work with internal teams in ensuring communication is sent out through the right channel regarding the latest product enhancements, fixes and versions
  • Do sanity of enhancements made
  • Performing other CDH Platforming activites like Study onboarding, Vendor registration, Source system set up, Data ingestion
  • Raising tickets and managing Jira board
  • Manage product deliverables and timelines by coordinating with Senior management and cross functional teams.
  • Developed product documentation to communicate upcoming features and products to internal teams.

Clinical Data Manager Scientist

Accenture
Hyderabad
09.2020 - 05.2022
  • Worked as a PDM for managing database set-up project from the time of draft protocol until Go-Live, conduct and until the database lock
  • Lead operations team meetings, meeting frequently with the study leads of coding, SAE Recon team, EDS team to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations
  • Effectively communicating data-driven discussions in order to achieve database lock dates with the highest possible data quality
  • Report to Lead DM for all tasks regarding operations team status (Coding, Ext Data Specialists, Data Reviewers, SAE recon)
  • Work with the LDM to build study milestone timelines and demonstrates capability to read and follow study timelines for on-time deliverables
  • Responsible for preparation of UAT Plan, edit check specification, Data Management Plan Preparation, CRF completion guideline preparation and preparation of Protocol Data Review Plan
  • Run metrics as appropriate for the operations team to review for productivity, quality and on time delivery
  • Support internal initiatives for operations department
  • Work with Line Manager on staff assignments and trainings for assigned resource
  • Coordinate with DM study team to ensure the receipt of all data related information is delivered within agreed upon timelines
  • Conducting knowledge sharing Session for Study Team
  • Communicating with eClinical vendors, database programmers, statistics & programming team, LSH specialist
  • Contribute to the development and implementation of departmental policies, standards and process improvement initiatives
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Skilled at working independently and collaboratively in a team environment.
  • Resolved problems, improved operations and provided exceptional service.

Clinical Data Analyst II

Syneos Health
Pune
01.2017 - 09.2020
  • Attend Study Team weekly telecoms and Update the team on DM issues
  • Performing UAT of database and edit checks and documentation of the same
  • CPT generation and send it to LDM and PL
  • DRP review and allocation with team members
  • Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
  • Vendor reconciliation (ECG, Lab, PK,)
  • Perform Early Process Review and final database QC activities
  • Self-motivated, with a strong sense of personal responsibility.
  • Skilled at working independently and collaboratively in a team environment.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Proven ability to learn quickly and adapt to new situations.

Clinical System Tester

PRA Health
Hyderabad
04.2016 - 12.2016
  • Validation of EDC systems - Building Validation / Test Plans, Test Scripts, Validation Reports
  • Performed UAT for EDC system OC-RDC and Rave, IVRS/IWRS, ePro.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Worked effectively in fast-paced environments.

Junior Data Analyst CDM

Cognizant Technology Solution
Mumbai
05.2014 - 04.2016
  • Worked in set up, Conduct & closeout phase of the trial
  • Maintains full understanding of study documentation, including the protocol, in order to perform proper execution of data management activities
  • Reviewing study data as per study protocol requirements
  • Performs discrepancy management in accordance with the Study DMP, DCS and according to agreed upon timelines
  • Communicates site data issues (dataflow, discrepancies, etc.) with Monitors, Line Manager and colleagues on the Study Data Management Team
  • Performing Lab data reconciliation, SAE reconciliation
  • Communicating with Sponsors for the study updates by providing status report and via study call
  • Creating Edit check specification, Validation plan, UAT.

Clinical Research Coordinator

Freelance
Nagpur
04.2011 - 04.2014
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Gathered, processed, and shipped lab specimens.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Followed informed consent processes and maintained records.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Strengthened communication skills through regular interactions with others.

Education

Bachelor of Pharmacy - Pharmacology And Toxicology

JLCCP
Nagpur
07.2007 - 2010.09

Diploma in Pharmacy - Pharmacy

Gurunanak College of Pharmacy
Nagpur
04.2005 - 2007.05

Skills

    Product Owner

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Accomplishments

Project Management Support Certificate

Tableau Desktop Certified Professional Certification

Agile Certified Practitioner (PMI-ACP)

Six Sigma Black Belt Certification

ICH-GCP

Shining Star Award

Software

CDMS, CTMS

JIRA

DBeaver PL SQL

Tableau, Google Data Studio

Timeline

Product Manager

Saama Technology
05.2022 - Current

Clinical Data Manager Scientist

Accenture
09.2020 - 05.2022

Clinical Data Analyst II

Syneos Health
01.2017 - 09.2020

Clinical System Tester

PRA Health
04.2016 - 12.2016

Junior Data Analyst CDM

Cognizant Technology Solution
05.2014 - 04.2016

Clinical Research Coordinator

Freelance
04.2011 - 04.2014

Bachelor of Pharmacy - Pharmacology And Toxicology

JLCCP
07.2007 - 2010.09

Diploma in Pharmacy - Pharmacy

Gurunanak College of Pharmacy
04.2005 - 2007.05

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Nilesh KakdeProduct Owner, Business Analyst, CDM, Life Science