Summary
Overview
Work History
Education
Skills
Accomplishments
Software
Timeline
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Sagar Jadhav

Sagar Jadhav

Sr. Clinical Data Manager
Mumbai,India

Summary

Dedicated Data Management professional with 13 years history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.


Proficient in handling trial responsibility throughout the data-management lifecycle. Advanced skills in EDC systems, expert in database design, study conduct and database lock

Overview

12
12
years of professional experience
7
7
years of post-secondary education
3
3
Languages

Work History

Sr. Clinical Data Manger

IQVIA
Mumbai, India
04.2020 - Current
  • Managing customer relationship for DM customer, negotiation on timeline and budgetary with guidance of Project Team.
  • Managing project timelines, determining resource needs and identify and justify out-of scope activities. Preparing Project Plan for the study and Interact with CDM team members to negotiate timelines and responsibilities.
  • Schedule and lead meetings with Customer and internal and external teams (Clinical team, Medical Monitors, DM team, Biostatisticians, Programmers, Coder and Thirds party vendors) to discuss the timelines and achieve the same as per the Project Plan on regular basis.
  • Preparing and presenting study updates and metrics in the Data Review team meeting with client.
  • Developed and reviewed data management documents such as Data Management Plan, Edit Check Specification, Data Review Plan, Configuration Specification, eCRF Specification, SAE Plan, CRF Completion Guidelines, Test Scripts and shared with Client for their review and approval.
  • Highly experienced on Study startup, conduct and eTMF activities.
  • Preparing daily workloads for staff & coordinating the daily allocation of work.
  • Quality Metrics: Error analysis, trend analysis, Participate in calibration calls with Client.
  • Drove operational improvements which resulted in savings and improved profit margins.
  • Proved successful working within tight deadlines and fast-paced atmosphere.
  • Carried out day-to-day duties accurately and efficiently.
  • Resolved problems, improved operations and provided exceptional service.
  • Managed team of employees, overseeing hiring, training and professional growth of employees.
  • Worked with customers to understand needs and provide excellent service.
  • Identified issues, analyzed information and provided solutions to problems.

Senior Clinical Data Manager

PAREXEL
Bangalore, India
07.2016 - 03.2019
  • Was working as Study Team Lead (STL).
  • Managing customer relationship for CDM project team including active participation in DM customer negotiation on timeline and budgetary with guidance of Line Manager. Managing project timelines, determining resource needs and identify and justify out-of-scope. Preparing Project Plan for the study and Interact with CDM team members to negotiate timelines and responsibilities.
  • Schedule and lead meetings with Customer, Clinical team, Medical Monitors, DM team, Biostatisticians, Programmers and Coder to discuss the timelines and achieve the same as per the Project Plan on regular basis.
  • Preparing and presenting study updates and metrics in the Data Review team meeting with client.
  • Developed and reviewed data management documents such as Edit Check Specification, Configuration Specification, eCRF Specification, SAE Plan, CRF Completion Guidelines, Test Scripts and shared with Client for their review and approval. Also worked on User Acceptance Testing (UAT) of the edit checks and Offline listings.
  • Worked on activities such as Queries, Offline listings, Dataset Reviews, Local Lab data, Central Lab data and SAE reconciliation.
  • Worked on Study close out activities like tracking the queries, missing visit and pages, freezing forms, sign off from investigators, locking the subjects and requesting CDs
  • Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG).
  • Preparing daily workloads for staff & coordinating the daily allocation of work.
  • Mentoring team members on the required study activities and perform comprehensive quality control procedures.
  • I am a database SME for 2 years and impart database related trainings regularly

Senior Clinical Data Manager

Inventiv International Pharma services Pvt Ltd
Pune, India
07.2015 - 07.2016

Lead Clinical Data Manager

Cognizant Technology Solutions India Pvt. Ltd.
Mumbai, India
03.2009 - 07.2015

Education

Master of Science - Clinical Research

Cranfield University
UK
08.2008 - 06.2010

Post Graduate Diploma in Clinical Research - Clinical Research

Institute of Clinical Research India
Mumbai, India
08.2008 - 08.2009

Bachelor of Pharmacy -

Pune University
Pune, India
06.2003 - 06.2007

Skills

    Therapeutic area expertise: Vaccine, Diabetes, Oncology, Neurology, and Hematology (Rare diseases) , Device

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Accomplishments

    Cognizant Lean Six Sigma certified

Software

Rave X, Medidata RAVE 564, IBM, DataLabs, Viedoc, OC paper and RDC, Inform 45, 46, 60, Clintrial 46

Timeline

Sr. Clinical Data Manger

IQVIA
04.2020 - Current

Senior Clinical Data Manager

PAREXEL
07.2016 - 03.2019

Senior Clinical Data Manager

Inventiv International Pharma services Pvt Ltd
07.2015 - 07.2016

Lead Clinical Data Manager

Cognizant Technology Solutions India Pvt. Ltd.
03.2009 - 07.2015

Master of Science - Clinical Research

Cranfield University
08.2008 - 06.2010

Post Graduate Diploma in Clinical Research - Clinical Research

Institute of Clinical Research India
08.2008 - 08.2009

Bachelor of Pharmacy -

Pune University
06.2003 - 06.2007

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Sagar JadhavSr. Clinical Data Manager