Akshay Kelji
Mumbai
Summary
To thrive in an atmosphere of challenges and opportunities that will facilitate the growth of my organization as well as my career simultaneously.
Overview
15
15
years of professional experience
Work History
Feasibility Manager
Biorasi
07.2022 - Current
- Lead team in conducting global feasibility activities (Including both pre-award and post-award feasibilities)
- Manage global feasibility team which assist our internal program development team in assessing feasibility and creating bids/proposals/ppts for bid defenses.
- Creating feasibility strategies which include country and site recommendations, analyzing the competitive environment and carrying out enrolment benchmarking analysis, providing list of recommended sites/investigators per country, proving country/site mix for the proposal, generating the survey, and carrying out pre-award and post-award feasibility outreach, gathering the feasibility outreach responses and summarizing the results into report to be provided to the sponsors.
- Oversee and track incoming responses and assign suitable team member for the new incoming request.
- Ensuring team updates and maintains the database of potential sites and investigators.
- Provide training to new employees on the overall feasibility process.
- Develop and strengthen relations with KOL’s of respective therapeutic areas.
- Oversee collaborations with SMO’s assisting us in the feasibility process.
- Perform interim/annual performance appraisal of assigned team members and identify gaps and propose development plans.
- Review and approve timesheets, requests for leaves, expense reports of assigned team members.
Global Feasibility Lead
Syneos Health
04.2019 - 06.2022
- Assists with design of study specific questionnaires for collection of metrics based global feasibility information for individual countries, sites, patient populations, etc.
- Programming the survey and sending it to Investigators from the site list generated.
- Performs scientific literature search for relevant articles that would support the feasibility analysis.
- Co-ordinate with internal and external team for collection of feasibility data.
- Perform ‘data mining’ for historical data for the relevant feasibility information in support of the ongoing opportunity.
- Assist the team in preparing material for bid defense meetings.
- Performs investigator database searches for feasibility and site selection as required.
Global Feasibility Analyst
IQVIA
12.2015 - 03.2019
- Act as a key analytics interface with the sales, proposal, and project teams and need to interpret requests and provide information to support the overall business need.
- Oversee and coordinate analytics requests (both Asia Pac and with Global counterpart) for the design, development and delivery of analytics solutions to support and enhance IQVIA R&D and RWI Solutions opportunities and trial programs.
- Partner with other R&D and RWI Solutions functions in a consultative manner to define analytic requirements to support trial strategy.
Junior Medical Writer
Sciformix Technologies Private Limited
05.2012 - 11.2015
- Creating, updating and reviewing regulatory documents (USPI, SPC, CSP and CDS) for consistency with the source documents/data.
- To carry out extensive literature search to provide latest and high-quality references to meet client’s expectations.
- To provide supporting/justification document for proposed label changes.
- Check documents for consistency with respect to grammar, formatting and information as per with style guides and regulatory guidelines/templates.
- To participate in client meetings encouraging and facilitating the exchange of scientific knowledge and expertise.
- System and workflow management of labeling documents.
- To ensure timely submissions of the documents.
- Responsible and accountable for managing and facilitating the document review, including consolidating and resolving review comments and incorporating agreed upon reviewer comments into the document prior to final approval.
- Trained on aggregate reports (PSUR and CAR).
Process Associate
Tata Consultancy Services
01.2011 - 04.2012
- Maintaining clinical study progress data and running metric reports for management of clinical trials.
- Quality check of the regulatory submission form (Form 1572) and logging the discrepancies.
- Collecting, summarizing, and reporting investigator financial information in a financial disclosure capturing system.
- Supplying of investigational product to site via electronic system.
- Analysis of debarred investigator’s list and generating debarment certificates.
- Certified trainer by client for the process.
- Handling long term follow up studies (Oncology studies).
Education
M.Sc. - Clinical Research
Cranfield University
01.2010
Post Graduate Diploma - Clinical Research Management
Institute of clinical research
01.2009
Graduate - Biotechnology
Mumbai University
01.2008
Skills
- Good Communication Skills
- Optimist
- Headstrong
- Self-Motivated
Publications
- Co-author for article on Duchenne Muscular Dystrophy (Article title- Survey Highlights Patient Recruitment Challenges in Duchenne Muscular Dystrophy Clinical Trials) which was published in Journal for Clinical Studies- April 2019
- Co-author for a white paper published on highlighting the importance of global proactive feasibility studies in rare disease (White Paper Title- Using Global Proactive Feasibility Studies to Identify Rare Disease Patients for Clinical Trials) published date-August 2020.
- Co-author for a white paper published on Hepatocellular Carcinoma: Consider India for your Next HCC International Trial which was published in Clinical Leader Journal- November 2023.
- Co-Author for a white paper on Spotlight on India: Regulatory Enhancements, Modernization, and Robust Data Collection Define India as a Potential Clinical Trial Hub which was published in Clinical Leader Journal-July 2024.
Training
- Was part of the conference for “BIOTECHNOLOGY- THE ROAD AHEAD” at Sophia College (Mumbai)
- Successfully completed project training entitled “PLANT TISSUE CULTURE” and “IMMUNOTECHNOLOGY” at Shreedhar Bhatt’s laboratory (Bengaluru)
Disclaimer
I hereby declare that all the information furnished above is correct and complete to the best of my knowledge.
PERSONAL DETAILS
- Permanent address: B-1701 Siennaa Towers, Samata Nagar, Opposite to Alpine Towers, Kandivali East, Mumbai 400101.
- Date of birth: 17th May 1987.
- Gender: Male.
- Marital status: Married.
- Language: English, Hindi, Marathi.
Timeline
Feasibility Manager
Biorasi
07.2022 - Current
Global Feasibility Lead
Syneos Health
04.2019 - 06.2022
Global Feasibility Analyst
IQVIA
12.2015 - 03.2019
Junior Medical Writer
Sciformix Technologies Private Limited
05.2012 - 11.2015
Process Associate
Tata Consultancy Services
01.2011 - 04.2012
Post Graduate Diploma - Clinical Research Management
Institute of clinical research
Graduate - Biotechnology
Mumbai University
M.Sc. - Clinical Research
Cranfield University
Similar Profiles
Gabriel GarciaGabriel Garcia
Creative Marketing Leader at BiorasiCreative Marketing Leader at Biorasi
Dr FATOU BIN NDURE, MDDr FATOU BIN NDURE, MD
Lead, Drug Safety Physician at BiorasiLead, Drug Safety Physician at Biorasi
Shruti PanchalShruti Panchal
Specialist, Quality Assurance at Biorasi CRO Services Pvt Ltd.Specialist, Quality Assurance at Biorasi CRO Services Pvt Ltd.
Aneri NanduAneri Nandu
Media Insight Analyst. at OnclusiveMedia Insight Analyst. at Onclusive
Sachin KumarSachin Kumar
Sr. Product Designer at Sky2C Logistics IncSr. Product Designer at Sky2C Logistics Inc