Summary
Overview
Work History
Education
Skills
Therapeutic Area, Indication with Phases
Languages
Accomplishments
Languages
Hobbies and Interests
Websites
Certification
Timeline
Generic

DEEPAK SHARMA

Dombivli

Summary

Dynamic Clinical Research Associate with extensive experience at many organizations, including sponsors and CROs, excelling in study budget negotiation and risk analysis. Proven track record in enhancing site performance and achieving recruitment targets through effective communication and superior organizational skills. Adept at navigating ICH GCP guidelines and fostering strong relationships with sponsors and sites.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Executive- CRA

Sun Pharma Laboratories Limited
Mumbai
01.2024 - Current
  • Conducted site feasibility assessments and identified potential investigators for studies.
  • Negotiated study budgets and finalized contracts with investigators and sites.
  • Oversaw preparation and submission of ethics committee dossiers and related communication letters.
  • Managed IP dispensing, inventory management, and reconciliation processes effectively.
  • Ensured timely execution of SQV, SIV, SMV, and SCV with accurate reporting.
  • Trained site staff and principal investigators on protocol compliance and local regulations.
  • Facilitated timely recruitment of trial subjects, data entry, source data verification, and query resolutions.
  • Identified risks, performed analysis, and developed corrective action plans for underperforming sites.

CRA

Tech Observer
Thane
09.2021 - 12.2023
  • Utilized SOP concepts and practices efficiently for all delegated tasks under time constraints.
  • Initiated budget discussions and recruited investigators in accordance with CRO/sponsor SOPs, GCP, and DCGI regulations.
  • Conducted on-site and remote monitoring visits, adhering to CRO/sponsor SOPs, monitoring plans, GCP, and local NCDT rules.
  • Facilitated investigator meetings through preparation, liaison work, presentations, problem resolution, and follow-up.
  • Ensured timely submission of EC Dossier for ethical committee/IRB approval.
  • Maintained TMF and SMF while reviewing ISF and regulatory documentation per CRO/sponsor SOPs and GCP.
  • Motivated investigators to achieve recruitment targets while maintaining effective communication with internal clients and vendors.
  • Supported compliant AE/SAE reporting as per sponsor/CRO SOPs, protocol, GCP, and local guidelines.
  • Collaborated closely with team members to achieve project objectives and meet deadlines.

Clinical Research Associate

IDD
Hyderabad
01.2021 - 09.2021
  • Executed clinical monitoring of studies, ensuring smooth site management and study conduct.
  • Acted as primary contact for assigned sites, facilitating communication among sponsors, PMs, and vendors.
  • Conducted site identification, feasibility assessments, selection, initiation, monitoring, close-out, and archival activities.
  • Supported project coordination activities, including start-up tasks and study updates for Project Manager.
  • Delivered site training aligned with project requirements to enhance compliance and performance.
  • Assisted QA team and sponsors during site audits and inspections to ensure adherence to standards.
  • Drove project deliverables at the site level, focusing on subject recruitment, retention, and data quality.
  • Prepared timely monitoring reports and letters using approved company/sponsor documentation.

Clinical Process Associate

IQVIA
Thane
03.2019 - 12.2020
  • Provided project assistance for all assigned projects and teams.
  • Ensured adherence to SOPs, policies, and regulatory requirements while meeting quality metrics.
  • Completed role-specific training and assessments on time, including self-learning courses and instructor-led sessions.
  • Conducted centralized monitoring activities with minimal supervision, including database maintenance for participating sites.
  • Coordinated access for site, clinical, and project management teams to facilitate operations.
  • Ensured timely completion of documentation for regulatory dossiers related to kit and sample shipment.
  • Released accurate patient laboratory reports by following up on pending activities and teams, providing weekly and periodic reports.
  • Participated in departmental initiatives and served as a buddy for new hires.

Education

MBA - Operations Management

Prin. L. N. Welingkar Institute of Management
Mumbai
12.2023

Bachelor of Science - Biotechnology

Ramniranjan Jhunjhunwala College
Mumbai
06.2018

HSC (XII) - Science

K.V. Pendharkar College
Mumbai
06-2015

SSC (X) -

B.R. Madhvi English School
Dombivli
06-2013

Skills

  • Remarkable knowledge of ICH GCP guidelines, US-FDA, NDCT rules, etc
  • Hands-on experience for Octalsoft IWRS, CTMS, Cronos EDC, Siebel Clinical Trial Management System (CTMS), Veeva Vault, Oracle, CTMS, EIMS, ERT, Ramos NG, SharePoint, Qlims, CTMS, Clinevo, EDC, and systems
  • Good Knowledge of Therapeutic Indications in Clinical Trials with Indian local regulations
  • Ability to understand and extract information from medical records
  • Good communication skills, decision-making skills
  • Superior organizational, record retention, and time management skills
  • Admirable service to sites, sponsors, and other clients
  • Team leadership and mentoring skills
  • Ability to stay calm under pressure
  • Good Knowledge of MS Office (PowerPoint Presentations), computer skills and time management skills
  • Study budget negotiation
  • Risk identification and analysis

Therapeutic Area, Indication with Phases

  • Therapeutic area as CRA
  • Gastroenterology (Erosive esophagitis, GORD) - Phase III, IV
  • Pulmonology (Bronchial Asthma, COPD, Severe Eosinophilic Asthma, )-Phase III, IV
  • Gynecology (uterine fibroids) - phase III
  • Psychiatry (Bipolar II)-Phase III
  • Endocrinology (Type II Diabetes Mellitus) -Phase III, IV
  • Bone Disease (Osteoporosis) -Phase IV
  • Oncology (Breast Cancer)- Phase IV
  • Dermatology (Scar on skin)-Phase IV
  • Nephrology (CKD) -Phase IV
  • Therapeutic area as Clinical Process Associate:
  • Hematology/Oncology- Phase I, III and IV
  • Allergy/ Immunology- Phase II and III
  • Cardiovascular: Phase I and III
  • Oncology- Phase I and II
  • Nephrology- Phase III
  • Endocrinology- Phase III

Languages

English
First Language
Hindi
Advanced (C1)
C1
Marathi
Intermediate (B1)
B1

Accomplishments

  • SSV- > 110, SIV- >70, SMV- > 250, SCV- > 50
  • Best Project Team on Quality Award for Fexuprazan P III study in Sun Pharma
  • Received Star Performer of the Month Award for 3 times in IDD Research Solutions Pvt. Ltd as CRA.
  • Received Spotlight award in IQVIA for two times
  • Worked on More than 10 trials as a CRA for local as well as global trials from Startup to Closeout in different Indications.

Languages

English, Hindi, Marathi

Hobbies and Interests

Hobbies : Reading books, Travelling and Playing  Outdoor games.

Certification

  • Certified Associate in Project Management (CAPM) Certified- Simplilearn
  • ICH GCP Certificate valid till Sep 2027
  • Scrum Foundation Professional Certificate by Certiprof
  • Agile Project Leadership and Six Sigma Green Belt- Linkedin
  • Pharmacovigilance Training- Sun Pharma
  • Passed Government MS-CIT course

Timeline

Executive- CRA

Sun Pharma Laboratories Limited
01.2024 - Current

CRA

Tech Observer
09.2021 - 12.2023

Clinical Research Associate

IDD
01.2021 - 09.2021

Clinical Process Associate

IQVIA
03.2019 - 12.2020

MBA - Operations Management

Prin. L. N. Welingkar Institute of Management

Bachelor of Science - Biotechnology

Ramniranjan Jhunjhunwala College

HSC (XII) - Science

K.V. Pendharkar College

SSC (X) -

B.R. Madhvi English School

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