Summary
Overview
Work History
Education
Skills
LinkedIn URL
Software
Accomplishments
Additional Information
Work Preference
Work Availability
Timeline
Hi, I’m

Prasad Wadgane

Experienced Professional
Mumbai
Prasad Wadgane

Summary

Experienced Registered Pharmacist with a diverse background in Clinical Research, MedDRA Coding, Pharmacovigilance, Trial Master File, and Project Assistance. Proficient in Dermatology and Rheumatology Therapeutic Areas, Project Management, administrative duties, TMF Reference Model, Configuration Manual, eTMF completeness, and reconciliation. Skilled in email filing, invoice processing, CTMS site contact list upload, and EDC/IWRS preparation. Completed a comprehensive Clinical Research Training Program in the US. Successfully collaborated with global teams both onsite and remotely. Possess a willingness to travel domestically and internationally for work-related assignments. Has professional experience and exposure in Malaysia, Singapore, Japan, and the US. Aware about Asana/Trello Project Management software tools. Hands-on experience with Trial Interactive and Argus softwares. Successful experience in team management with recognized strength in client management.

Overview

10
years of professional experience

Work History

Arco Verde Kft.
Remote

Business Development Specialist
12.2023 - Current

Job overview

  • Collaborated with International Business Development Manager, CEO, COO, and Founder in Hungary
  • Presented smart vending machine SOS Pharmatic® and its benefits to key-decision makers
  • Initiated and maintained contacts with key-decision makers to explore partnership opportunities
  • Conducted independent research to identify and engage with pharmaceutical industry stakeholders

-
Remote

Project Lead
11.2021 - 11.2023

Job overview

  • Led a team to achieve all milestones on time, resulting in a 20% increase in project efficiency
  • Established specific plans to ensure the successful attainment of project objectives, contributing to a 15% reduction in project timeline
  • Managed challenging situations promptly and effectively, maintaining project momentum and ensuring minimal disruption
  • Motivated team members to efficiently complete their assigned tasks, resulting in a 25% improvement in overall project productivity
  • Evaluated team members' performance and provided targeted guidance, contributing to a 10% increase in their expertise and the project's performance
  • Fostered a spirit of teamwork among team members, enhancing collaboration and optimizing individual contributions for a cohesive project outcome

Innovaderm Research Inc
Remote

Clinical Project Assistant
09.2021 - 11.2021

Job overview

  • Executed all tasks before deadlines, including conducting eTMF reconciliation, filing emails, and managing EDC/IWRS, resulting in a 90% improvement in work quality. Supported the project team for assigned studies in Dermatology Therapeutic Area, contributing to successful project outcomes
  • Initiated and maintained eTMF through Trial Interactive, ensuring smooth data management
  • Downloaded monitoring reports and confirmation letters from CTMS and sent them for upload to eTMF, maintaining accurate project records
  • Filed email correspondences in eTMF and assigned CRAs to sites, ensuring organized documentation and effective site communication
  • Assisted in maintaining projects and updating site status in CTMS, enhancing project efficiency
  • Reconciled vendor invoices against vendor contracts, ensuring financial accuracy and adherence to contracts
  • Aided in project tracking activities and prepared status reports, facilitating efficient project management
  • Engaged in various administrative tasks as required to accomplish project goals, ensuring smooth project operations
  • Collaborated effectively with the Directors and Managers of the Canadian team, contributing to a cohesive and successful work environment

TransPerfect Solutions India Private Limited
Remote

eTMF Specialist
02.2021 - 05.2021

Job overview

  • Streamlined the coding of FDA 1572, Investigator Brochure, Medical Licenses, CVs, Monitoring Visit Report/Letter, IRB Approval, Protocol, Informed Consent, Signature Page, and Safety Reports for various clinical trial phases within a tight deadline of 3 months
  • Enhanced efficiency by accurately coding 617 documents within a 2-month timeframe, achieving an exceptional 86% quality work rate
  • Led the Quality Control and review process of study documentation for Trial Master File (TMF) quality, establishing a reputation as a Site Level Document Specialist
  • Independently coded site-level documents and demonstrated expertise in Trial Master File Reference Model
  • Added metadata to the electronic Trial Master File and utilized Trial Interactive for seamless document management
  • Actively participated in weekly/biweekly meetings with Project Managers to address project issues and provide status updates
  • Collaborated with cross-functional teams, including Project Management, Business Development, Client Services, Development, and IT, to effectively implement and manage client projects
  • Contributed as part of the Project Team, ensuring the set client expectations were met and exceeded
  • Coordinated and standardized operations across global teams to ensure consistency and uniformity in processes
  • Collaborated with TransPerfect US & UK Trial Master File teams to enhance operational effectiveness

CRO
Remote

Clinical Research Trainer
09.2018 - 01.2021

Job overview

  • Recruited and trained students virtually as a Clinical Research trainer into Clinical Operations
  • Assisted students in achieving their career goals, including resume preparation and interview techniques

Professional Global Clinical Research Organization
Phoenix , AZ

Attendee
04.2018 - 08.2018

Job overview

  • Participated in ACRP and SoCRA conferences to stay updated on industry trends and best practices.
  • Traveled extensively within the US for business activities, successfully establishing rapport with diverse cultures and communities.
  • Proactively engaged with individuals from different cultural backgrounds to foster meaningful relationships and expand professional network.

Arizona Arthritis and Rheumatology Clinic, P.C
Sun City, AZ

Clinical Research Coordinator
03.2018 - 03.2018

Job overview

  • Contributed to the Rheumatology Therapeutic Area by actively participating in Phase IIIB, Randomized, Double-blind Clinical Trial.
  • Executed phlebotomy and conducted patient chart screening for arthritis trials, ensuring accurate and reliable data collection.
  • Facilitated Site Initiation Visit to the Glendale, Arizona site, in collaboration with the Clinical Research Associate.
  • Gained hands-on experience with Case Report Form, Electronic Data Capture, Source Document Verification, Regulatory Binder, Data Query, and Patient Visit processes.
  • Supported the successful execution of the clinical trial by actively engaging in site activities and ensuring quality data collection.

Family Business
Navi Mumbai, MH

Business Associate of Shops
05.2016 - 02.2018

Job overview

  • Spearheaded expansion of agricultural and commercial property operations, driving operational efficiency and achieving a 40% increase in profits by selling to the local market and delivering exceptional customer service
  • Conducted visits to Malaysia, Singapore, and Japan to engage high-profile clients and address their financial requirements

Cognizant Technology Solutions Private Limited
Navi Mumbai, MH

Drug Safety Associate
11.2015 - 04.2016

Job overview

  • Managed and executed Pharmacovigilance case processing activities including collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events
  • Conducted product coding using the WHO dictionary
  • Performed adverse event coding using the MedDRA dictionary and oversaw all case-related information, including interpretation of medical conditions and lab results
  • Compiled comprehensive narrative summaries for case reports
  • Collaborated with teams at Cognizant Hyderabad, Pune, and Argentina to ensure seamless operations

Integreon Managed Solutions Private Limited
Mumbai, MH

MedDRA Coder
01.2015 - 04.2015

Job overview

  • Coded 12500 MedDRA terms using MedDRA dictionary during a 4-month contract MedDRA project
  • Utilized MedDRA dictionary to code diseases, symptoms, and diagnoses
  • Contributed to the therapeutic incompatibilities section in the Summary of Medicinal Product Characteristics
  • Supported EMEA marketing authorization filings

Education

Clinical Research Fastrack

Clinical Research Training
03-2018

Institute of Clinical Research India Private Limited

Post Graduate Diploma in Clinical Research & Pharmacovigilance
01.2015

MET Institute of Pharmacy

Bachelors of Pharmacy
07-2013

Sysplex Bio & Clinical Solutions Private Limited

Post Graduate Diploma in Regulatory Affairs
07-2012

Bharati Vidyapeeth's College of Pharmacy

Diploma in Pharmacy
01.2005

Skills

  • EDC
  • IWRS
  • CTMS
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Argus
  • Trial Interactive
  • Google Docs
  • Adobe Acrobat
  • Microsoft Outlook
  • Microsoft Office 365
  • Microsoft Teams
  • Zoom
  • Skype
  • Healthcare
  • ALCOA
  • WHO DD
  • MedDRA
  • ICH GCP E6 R2
  • Drug Development
  • Clinical Research
  • Clinical Trials
  • Case Report Form
  • Informed Consent Form
  • ETMF
  • Metadata
  • TMF Reference Model
  • Records Management
  • Clinical Project Management
  • Clinical Protocol
  • Clinical Operations
  • Clinical Data
  • Rheumatology & Dermatology Therapeutic Areas
  • Medical Terminology
  • Site Initiation Visit
  • Business Development
  • Stakeholders
  • Vendor Management
  • Leadership
  • Organizational
  • Strong Communication
  • Team player
  • Adaptability
  • Problem-solving
  • Decision-making
  • Interpersonal abilities
  • Strategic Thinking
  • Project Management

LinkedIn URL

https://www.linkedin.com/in/pwadgane

Software

Trial Interactive

Argus

Bioclinica CTMS

Asana

Trello

Accomplishments

  • Collaborated with team of 30 members when worked into Project Management as a Project Lead.
  • Received International Clinical Research Award for outstanding performance as secured 89%. Gained training through CEOs, Directors & VPs.

Additional Information

VISA STATUS

I am on B1/B2 visa for US valid

until February 2028. I was back in

2018 for 6 months. Open traveling to

US for work purposes.

Work Preference

Work Type

Full Time

Location Preference

RemoteOn-SiteHybrid

Important To Me

Company CultureCareer advancementWork-life balanceWork from home optionTeam Building / Company Retreats4-day work weekPersonal development programs
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Business Development Specialist

Arco Verde Kft.
12.2023 - Current

Project Lead

-
11.2021 - 11.2023

Clinical Project Assistant

Innovaderm Research Inc
09.2021 - 11.2021

eTMF Specialist

TransPerfect Solutions India Private Limited
02.2021 - 05.2021

Clinical Research Trainer

CRO
09.2018 - 01.2021

Attendee

Professional Global Clinical Research Organization
04.2018 - 08.2018

Clinical Research Coordinator

Arizona Arthritis and Rheumatology Clinic, P.C
03.2018 - 03.2018

Business Associate of Shops

Family Business
05.2016 - 02.2018

Drug Safety Associate

Cognizant Technology Solutions Private Limited
11.2015 - 04.2016

MedDRA Coder

Integreon Managed Solutions Private Limited
01.2015 - 04.2015

Clinical Research Fastrack

Clinical Research Training

Institute of Clinical Research India Private Limited

Post Graduate Diploma in Clinical Research & Pharmacovigilance

MET Institute of Pharmacy

Bachelors of Pharmacy

Sysplex Bio & Clinical Solutions Private Limited

Post Graduate Diploma in Regulatory Affairs

Bharati Vidyapeeth's College of Pharmacy

Diploma in Pharmacy

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Prasad Wadgane Experienced Professional