Summary
Overview
Work History
Education
Skills
Websites
Certification
Therapeutic Area Expertise
Key Experience
Disclaimer
Languages
Accomplishments
Timeline
Generic

Sandesh Kadam

Uran,MH

Summary

Meticulous, Astute and Competent; Clinical, Life Science and Pharmaceutical Professional with 10+ years of Vast and rich Experience in field of Clinical Research, Clinical Trials, Data Management and a Subject Matter Expert; Seeking, Probing and Re-considering an opportunity in and as Clinical Data Management/Manager

Overview

12
12
years of professional experience
1
1
Certification

Work History

Associate Data Team Lead

IQVIA
05.2023 - 02.2024
  • Working on areas such as PNH and Complement 3 Glomerulopathy.
  • Worked on Snapshots / Interim Analysis for the respective studies for every 4 to 5 months.
  • Third Party Vendor Reconciliation includes Biomarker ePRO, Central Lab, IRT, and ( PK Preadvance) .
  • Preparing Minutes of Meetings for Assigned Studies.
  • Preparing Early Close Out Plan for Early Close site activities after alignment with CTT & TDM.
  • Preparing and sharing Study Matrix (Clean Patient Tracker) with CTT Team and relevant stakeholders on Biweekly basis.
  • Collaborate / work with coding, medical, statisticians, Clinical Operations, Clinical Development, Global Trial Manager, and other line functions on Clinical trials.
  • Data Management Quality Review-as per DQPM checks, Domain's review from J Review.
  • Performed DDPASS Data Review.
  • Performed Discrepancy Management.
  • Accomplished Data Entry in EDC for Scanned hard copies of paper CRFs. Maintained Data Entry Trackers & Issues Logs for Paper CRFs.
  • Carried out Review of Various Data Listings & Reports like (AE, CMED, and MH), J reviewed listings from Rave in order to clean the data.

CDA III Worked on Third Party Payroll of ALLEGIS

IQVIA
01.2022 - 04.2023

    • Working on areas such as PNH and Complement 3 Glomerulopathy.

    • Worked on Snapshots / Interim Analysis for the respective studies for every 4 to 5 months.

    • Third Party Vendor Reconciliation includes Biomarker ePRO, Central Lab, IRT, PK (Preadvance) .

    • Preparing Minutes of Meetings for Assigned Studies.

    • Preparing Early Close Out Plan for Early Close site activities after alignment with CTT & TDM.

    • Preparing and sharing Study Matrix (Clean Patient Tracker) with CTT Team and relevant stakeholders on Biweekly basis.

    • Collaborate / work with coding, medical, statisticians, Clinical Operations, Clinical Development, Global Trial Manager and other line functions on Clinical trial.

    • Data Management Quality Review-as per DQPM checks, Domain's review from J Review.

    • Performed DDPASS Data Review .

    • Performed Discrepancy Management.

    • Accomplished Data Entry in EDC for Scanned hard copies of paper CRFs. Maintained Data Entry Trackers & Issues Logs for Paper CRFs.

    • Carried out Review of Various Data Listings & Reports like (AE, CMED, and MH), J Review Listings from Rave in order to clean the data.

Assistant Manager CDM

Cadilla Pharma
05.2021 - 12.2021
  • Manage clinical data vendors utilizing strategic communication skills that increases productivity, quality and punctual delivery of projects
  • Conduct protocol training to CRO data managers to understand primary and secondary end point
  • Effectively implemented staff trainings on research protocols and ICH GCP/GLP through in-service trainings, one-on-one in-person meetings, and in-house written communications
  • Conduct clinical data management functions such as data review, protocol review, CRF design and development, CRF review, database validation, query generation, and study outcome validation
  • Collaborates with external laboratories and clinical study personnel to ensure that adequate laboratory evaluations are obtained in accordance with protocol requirements and in compliance with GCP and/or authorized SOP
  • Review all external data reconciliation trackers and provide resolution comments to the vendor
  • Managed the conduct of studies including patient enrollments and randomizations
  • Act as a liaison between project client contacts, core team members, and project managers
  • Reviews data to gain understanding and knowledge of the study to accurately assess study status and data quality
  • Documented and addressed any errors, omissions, or inconsistencies found during data review and worked with project team both internal and external to resolved issues as needed
  • Managing and resolving discrepancies and DCF integration and resolving working with listings
  • Reviews data to gain understanding and knowledge of the study to accurately assess study status and data quality
  • Performed the validation of data fields captured in the database against the CRF when appropriate
  • Validated the completeness, accuracy and consistency of the clinical trial database on an ongoing basis through the use of ad hoc queries
  • Ensures User Acceptance Testing (UAT) is carried out and documented
  • Assist the Database Administrator with the design of the clinical study database in accordance with relevant procedures
  • Validate data entry screens and edit check programs
  • Actively participated in study debrief meetings, implements data management learning and contributed to activities to improve and maintain the quality and effectiveness of data management processes within the function
  • Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical trial database

Subject Matter Expert Clinical Trials

Sarjen Systems
01.2021 - 05.2021
  • Requirement gathering in regarding to regulatory software development i.e. Pharmacovigilance (PV) & Clinical Trial Management (CTM)
  • Further analysis work in conjunction with software development team
  • Sharing domain/subject knowledge with development team regarding complex regulatory solutions requirements
  • Providing support to clients in the successful implementation of the regulatory software
  • User (clients) training and documentation
  • Incorporating regulatory guidelines in the development of entire software
  • Consulting clients as a subject matter expert to share software domain/subject-related knowledge
  • Educating clients through social media platforms or webinars

Senior Clinical Process Associate

IQVIA
06.2018 - 09.2020
  • Prepared & Sent Dashboards for Various Therapeutic Areas While delivered it to Various Stakeholder like SGTM, CRAs, Site Managers, Data Managers, and SRS for respective studies.
  • Delivered Biweekly Action Items, Protocol Deviation Reports for review of SGTMS, CRAs, Data Managers for respective studies.
  • Performed eTMF Access Management for Eli Lilly Stakeholders.Arranged SDV& SVR Reports with the help of SCTMs System for Covance.Qualified Monthly Action Items Report, Protocol Deviation Report & Sending it to the review of CRAs, andSGTMs.
  • Actioned SAE/PD/ICF Report.
  • Assessed Status Wise Action Items Report from QCTMS System.

Data Manager

Cognizant
11.2016 - 06.2018
  • Conducted user acceptance testing to facilitate database upgrades and migrations - Ensured smooth transitions and minimized data integrity and functionality disruptions.
  • Proficient in developing comprehensive data management plans - Skilled in providing valuable input on study designs - Experienced in contributing to improved data collection, organization, and analysis processes.
  • Collaborated with cross-functional teams to execute clinical data collection studies using an electronic data capture (EDC) system, successfully developing, documenting, testing, and implementing research studies.
  • Collaborated closely with relevant stakeholders to develop and analyze electronic case report forms (eCRFs) and execute appropriate data validation checks, improving data quality and integrity.
  • Exhibited exceptional proficiency in performing reconciliation tasks for multiple data sources, including SAE (Serious Adverse Events), TPV (Third Party Vendor), PK/PD/Central & Local Lab (Pharmacokinetics/Pharmacodynamics), IVRS (Interactive Voice Response System),
  • Developed and implemented effective tracking and resolution processes for data-related issues during investigations. - Maintained an issue log tracker and adhered to predetermined rules to ensure thoroughness and accuracy.
  • Ensured the accuracy of clinical data within the Electronic Data Capture (EDC) system by performing detailed listings and queries.
  • Demonstrated effective command of data management queries by proactively addressing data coding issues. This proactive strategy ensured high-quality and accurate data, reducing errors and inconsistencies in the final datasets.
  • Meticulous reconciliation process resulted in the generation of complete and trustworthy datasets.

Data Manager

TCS
07.2015 - 11.2016
  • Clinical Data Manager on two individual Phase III randomized Dermatology studies
  • Clinical data management activities
  • Perform protocol level clinical data review and cleaning activities supporting the clinical trial and maintaining protocol data quality
  • Data Validation and Data cleaning by Peer-Reviewing
  • Proficient in handling Program files, Log files, Listing files and Data sets.
  • Interacted with statistician back and forth and discussed the various updates in the specification.
  • Identify study setup, and validation errors and provided resolutions tracked by the Issues and Decisions Log Write, review, and approve Data Management Plans and other key study documentation
  • Create, review, and process data clarification forms and update the database
  • Prepare case report form (CRF), validation reports, and trial evaluations

CRC (SITE SOLUTIONS EXECUTIVE)

Cytespace SMO
10.2014 - 06.2015
  • Supervised the successful collection, transport, and storage of biological samples, ensuring their integrity and compliance with study guidelines.
  • Demonstrated skills in data entry, maintaining accurate and current databases, and managing data queries effectively. This meticulousness and precision in data administration procedures ensured efficient and trustworthy data management processes.
  • Provided valuable guidance, resulting in the successful enrollment of qualified research participants. Utilized advice to develop effective participant recruitment strategies and recruit a diverse and skilled participant pool.
  • Conducted surveys and collected data analyzed data to draw insightful conclusions for research purposes - Utilized data collection methods to provide valuable insights for evidence-based decision-making.
  • Demonstrated proficiency in screening techniques, quickly identifying and determining the eligibility of potential research participants.
  • Experience in coordinating study procedures and managing participant study visits, ensuring smooth logistics, and providing a positive experience for participants Facilitated seamless coordination to create a positive study environment; ensured participant compliance and engagement.
  • Assisted patients with questionnaire completion, ensuring their comfort and comprehension. This supportive approach encouraged participants to provide accurate and thorough responses, thereby improving the quality and dependability of the data collected

C R C

Lambda CRO
06.2012 - 04.2013
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Act as Day & Night Custodian Cum Data Quality checker for BA BE Studies .
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Developed and maintained accurate and timely EDC entry in Biznet Software.
  • Assisted in the preparation of Institutional Review Board submissions for clinical trials.
  • Translational & Back Translation of CRFs in respective Languages
  • Performed patient assessments, collected and analyzed data, and prepared reports.
  • Monitored patient safety during BA BE trials according to established guidelines.
  • Prepared informed consent forms for review by ethics committees.
  • Educated participants on studies and anticipated outcomes.
  • Gathered and reviewed study data.
  • Reviewed CRFs for completeness and accuracy before database entry.

CDA

Caliber Point Solutions
11.2011 - 03.2012
  • Clinical Data Entry into EDC Software.
  • Quality Control of eCRF data entered in EDC Software.
  • Documentation of Error found during data entry in EDC in Client Issue Tracker.

Education

Post Graduate Diploma in Clinical Data Management - Clinical Data Management

Sysplex Bio & Clinical Solutions
Mumbai
01.2011

Diploma in Clinical Research & Clinical Data Management - Clinical Research & Clinical Data Management

Mitcon Bio-Pharma Centre
Panvel
01.2010

Bachelor of Science - Chemistry

Veer Wajekar Arts Science College
Uran, MH
05.2009

High School Diploma -

Veer Wajekar Arts Science Jr College ( HSC )
Uran
12.2005

SSC -

Kendriya Vidyalaya
Uran, MH
01.2002

Skills

  • Clinical trial phases (Phase I to IV)
  • Clinical Data Management activities
  • End-to-end CDM process
  • 21 CFR Part 11
  • Clinical Data Management Practice (GCDMP)
  • Validation procedures and discrepancy management and DCF
  • Study protocol and other relevant study documentation
  • Data Management Plan and CRF Completion Guidelines
  • EDC (Electronic Data Capture)
  • Trained on SAE reconciliation Third-party vendor data reconciliation
  • Freezing and Locking Activities
  • EDC Skills:
  • Oracle Clinical
  • Medidata Rave
  • Biznet
  • Octal Soft

Certification

  • Certification in Clinical SAS & Oracle, Sysplex Bio & Clinical Solutions, 2011
  • CProgramming, MCED, 65%, 2007
  • Basic Computer Course MSC-IT, MSBTE, 62%, 2006

Therapeutic Area Expertise

  • Psoriasis
  • Diabetes
  • Covid 19 Trials
  • Anti-Infective
  • CNS
  • ONCOLOGY

Key Experience

  • Clinical Data Management Working on areas such as PNH and Complement 3 Glomerulopathy., Worked on Snapshots / Interim Analysis for the respective studies for every 4 to 5 months., Third Party Vendor Reconciliation includes Biomarker ePRO, Central Lab, IRT, SAE, PK (Preadvance)., Preparing Minutes of Meetings for Assigned Studies., Preparing Early Close Out Plan for Early Close site activities after alignment with CTT & TDM., Preparing and sharing Study Matrix (Clean Patient Tracker) with CTT Team and relevant stakeholders on Biweekly basis., Collaborate / work with coding, medical, statisticians, Clinical Operations, Clinical Development, Global Trial Manager and other line functions on Clinical trial., Data Management Quality Review-as per DQPM checks, Domain's review from J Review., Performed SAE Reconciliation, Performed Discrepancy Management., Accomplished Data Entry in EDC for Scanned hard copies of paper CRFs. Maintained Data Entry Trackers & Issues Logs for Paper CRFs., Carried out Review of Various Data Listings & Reports like (AE, CMED, and MH), J Review Listings from Rave in order to clean the data
  • Senior Clinical Process Associate Prepared & Sent Dashboards for Various Therapeutic Areas While delivered it to Various Stakeholder like SGTM, CRAs, Site Managers, Data Managers, and SRS, Delivered Biweekly Action Items, Protocol Deviation Reports for review of SGTMS, CRAs, Data Managers, Performed eTMF Access Management for Eli Lilly Stakeholders, Arranged SDV& SVR Reports with the help of SCTMs System for Covance, Qualified Monthly Action Items Report, Protocol Deviation Report & Sending it to the review of CRAs, SGTMs, Actioned SAE/PD/ICF Report, Assessed Status Wise Action Items Collation from QCTMS System
  • Clinical Research Coordinator Performed Key Skills activities such as e-CRF Data Entry, CRF Completion, Source Documentation, DCF Resolution, ICF Completion, Maintain Trial Master File (TMF), Source Data Collection, Acted as Custodian, Assisted Screening Team in Recruitment of Patients, Coordinated with principal Investigator, Co-Investigator, Labs & Vendors, Handled documentation of various study data, Quality control of study data through Biznet, Maintaining a compensation track sheet of every study
  • Clinical Data Analyst ECRF Data Entry., QC OF ECRF Data.

Disclaimer

The above-furnished information is true to the best of my knowledge and belief

Languages

English
Advanced (C1)
Hindi
Advanced (C1)
Marathi
Advanced (C1)

Accomplishments

IQVIA :- Associate Data Team Lead :- Received Client Appreciation for Working for LNP023 / IPTACOPAN PHASE III Study

Timeline

Associate Data Team Lead

IQVIA
05.2023 - 02.2024

CDA III Worked on Third Party Payroll of ALLEGIS

IQVIA
01.2022 - 04.2023

Assistant Manager CDM

Cadilla Pharma
05.2021 - 12.2021

Subject Matter Expert Clinical Trials

Sarjen Systems
01.2021 - 05.2021

Senior Clinical Process Associate

IQVIA
06.2018 - 09.2020

Data Manager

Cognizant
11.2016 - 06.2018

Data Manager

TCS
07.2015 - 11.2016

CRC (SITE SOLUTIONS EXECUTIVE)

Cytespace SMO
10.2014 - 06.2015

C R C

Lambda CRO
06.2012 - 04.2013

CDA

Caliber Point Solutions
11.2011 - 03.2012

Post Graduate Diploma in Clinical Data Management - Clinical Data Management

Sysplex Bio & Clinical Solutions

Diploma in Clinical Research & Clinical Data Management - Clinical Research & Clinical Data Management

Mitcon Bio-Pharma Centre

Bachelor of Science - Chemistry

Veer Wajekar Arts Science College

High School Diploma -

Veer Wajekar Arts Science Jr College ( HSC )

SSC -

Kendriya Vidyalaya

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Sandesh Kadam