Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

Harshad Prabhakar Sawant

Sr. Global Site Activation Analyst
Pune

Summary

Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.

Dynamic individual with hands-on experience in Clinical Trial and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.

Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.

Overview

14
14
years of professional experience
1
1
Certification
3
3
Languages

Work History

Sr. Global Site Activation Analyst

IQVIA
11.2022 - Current
  • Independently or in collaboration with Site Activation Manager, develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
  • Oversee the execution of site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
  • Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  • Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
  • Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project specific information.
  • May be involved in activities related to monthly study budget planning and reviews.

Global Site Activation Analyst

IQVIA
04.2021 - 10.2022
  • Performs tasks associated with Site Activation and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
  • Serves as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Maintenance Lead (ML) Project Management team, and other departments as necessary. Independently performs activities in the absence of an assigned SAM and/or ML.
  • Provides strategic planning and project oversight related to start up and site activation activities and/or maintenance activities according to applicable regulations, SOPs and work instructions.
  • Reviews, establish and agrees on timelines and ensure monitoring measures are in place and implement contingency plan as needed.
  • Coordinates resource management and distributes completed documents to internal project team members.
  • Informs team members of completion of regulatory and contractual documents for individual sites.
  • Reviews, tracks and follows up on progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Reviews and provides feedback to management on performance metrics. Provides ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues as well as sponsors.
  • Creates and/or reviews technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Ensures accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project specific information.
  • Extends EAC (Financial Planning) and other financial support within scope as requested for the function.

Regulatory and Start Up Specialist-1

IQVIA
04.2018 - 03.2021
  • Generate report from database (Spotfire), analyze it and provide consolidated data to manager for Service Level Agreement performance review.
  • Receipt, review and tracking of Essential Documents within various systems pre and post SIV.
  • Tracking of submissions into the electronic trial management systems.
  • Well versed with internal systems including but not limited to CTMS, eTMF (ELVIS/Wingspan), Site Activation Workflow, RSU Workflow, RID.
  • Actively involved in the upload of IND packages and Health Authority Submission packages to Sponsor EDMS operating under very tight timelines.
  • Subject Matter Expert and POC for processes offered by cRSU and Tech Champion for newly introduced Site Activation Workflow.
  • Responsible for creation and updating of guidance documents and providing regular updates to the team based on information received.
  • Training, mentoring, buddying and tracking progress of new hires to ensure seamless and timely onboarding.
  • Active contributor to process improvement established by a continuous dialogue with the Leadership Team and key stakeholders.
  • Involved in escalation management and establishing preventive actions.
  • Knowledgeable about ICH-GCP and FDA Regulatory Requirements for Clinical Trials.

Sr. Clinical Process Associate

IQVIA
09.2017 - 04.2018
  • Perform assigned complex administrative tasks to support team members with project execution
  • Assist in updating and maintaining complex data in systems within project timelines and per project plans
  • Establish and maintain effective project/ site communications
  • Create and maintain relevant project documents
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tool sand project plans with project specific
  • Perform assigned tasks falls under different services :
  • Essential Document Pack all services – Performing Essential Document Review and Tracking entry in electronic trial management system.
  • Site ID and Feasibility services- Promotion and Association of site contacts in electronic trial management system.
  • Preparation of Study Binder for sites.
  • Submission and Approval Tracking in electronic trial management system.
  • Electronic Trial Master File Contract Upload process

Clinical Process Associate 2

IQVIA
09.2016 - 09.2017
  • Perform assigned complex administrative tasks to support team members with project execution
  • Assist in updating and maintaining complex data in systems within project timelines and per project plans
  • Establish and maintain effective project/ site communications
  • Create and maintain relevant project documents
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tool sand project plans with project specific
  • Perform assigned tasks falls under different services :
  • Essential Document Pack all services – Performing Essential Document Review and Tracking entry in electronic trial management system.
  • Site ID and Feasibility services- Promotion and Association of site contacts in electronic trial management system.
  • Preparation of Study Binder for sites.
  • Submission and Approval Tracking in electronic trial management system.
  • Electronic Trial Master File Contract Upload process

Clinical Research Associate

Raptim Research Pvt. Ltd
03.2014 - 07.2015
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
  • Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
  • Followed drug storage procedures to comply with protocols and SOP requirements.

Clinical Research Coordinator

GlaxoSmithKline Pharmaceuticals
03.2011 - 04.2013
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
  • Worked with principal investigator and CRA to facilitate daily trial activities and comply with research protocols.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Gathered, processed, and shipped lab specimens.
  • Collaborated with clinical Site staff and other healthcare professionals to support clinical trial data accuracy.
  • Collection and Triaging of AE reports received from clinical trials and post marketing activities.
  • Co-ordinate with regulatory people for notification of AE to regulatory authority.
  • Maintain and update safety logs and safety files.
  • Validation of adverse event reports (e.g. Spontaneous, Literature reports etc.)
  • Filing valid AE report in local Safety Database file.

Education

Master in Pharmaceutical Science - Pharmaceutical Sciences

Bharati Vidyapeeth College of Pharmacy
Mumbai, India
04.2001 -

Bachelor of Pharmacy - Pharmaceutical Sciences

Poona College of Pharmacy
Pune, India
04.2001 -

Skills

Documentation and reporting

Report preparation

Excel proficiency

Root-cause analysis

Team collaboration and leadership

Analytical thinking

Decision-making

Time management

Regulatory compliance

MS Excel

Accomplishments

  • Used Microsoft Excel to develop live dashboard for submission and approval status activities.

Certification

Licensed Registered Pharmacist

Timeline

Licensed Registered Pharmacist

06-2025

Sr. Global Site Activation Analyst

IQVIA
11.2022 - Current

Global Site Activation Analyst

IQVIA
04.2021 - 10.2022

Regulatory and Start Up Specialist-1

IQVIA
04.2018 - 03.2021

Sr. Clinical Process Associate

IQVIA
09.2017 - 04.2018

Clinical Process Associate 2

IQVIA
09.2016 - 09.2017

Clinical Research Associate

Raptim Research Pvt. Ltd
03.2014 - 07.2015

Clinical Research Coordinator

GlaxoSmithKline Pharmaceuticals
03.2011 - 04.2013

Master in Pharmaceutical Science - Pharmaceutical Sciences

Bharati Vidyapeeth College of Pharmacy
04.2001 -

Bachelor of Pharmacy - Pharmaceutical Sciences

Poona College of Pharmacy
04.2001 -

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Harshad Prabhakar SawantSr. Global Site Activation Analyst