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I am Manoj Acharya, MSc Clinical Study Management, based in Melbourne, with over 20 years of experience in monitoring, coordinating, and managing clinical trials across pharmaceutical companies and CROs. I am known for strong interpersonal and communication skills combined with a pragmatic, technically sound approach to Clinical Trial Services. I have led diverse multicentric global studies across oncology, infectious diseases, cardiovascular and other therapeutic areas, delivering high-quality results, achieving enrollment targets, and ensuring regulatory compliance. I am a proven leader with a track record of building partnerships with multicultural teams, investigational sites, and research institutes. I am seeking a leadership role within a research organization that offers challenges, learning opportunities, and professional growth, with a proactive mindset toward cost optimization.…I am Manoj Acharya, MSc Clinical Study Management, based in Melbourne, with over 20 years of experience in monitoring, coordinating, and managing clinical trials across pharmaceutical companies and CROs. I am known for strong interpersonal and communication skills combined with a pragmatic, technically sound approach to Clinical Trial Services. I have led diverse multicentric global studies across oncology, infectious diseases, cardiovascular and other therapeutic areas, delivering high-quality results, achieving enrollment targets, and ensuring regulatory compliance. I am a proven leader with a track record of building partnerships with multicultural teams, investigational sites, and research institutes. I am seeking a leadership role within a research organization that offers challenges, learning opportunities, and professional growth, with a proactive mindset toward cost optimization.

Manoj Acharya

Writer, Content Producer, Film Director, +2

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I am Manoj Acharya, MSc Clinical Study Management, based in Melbourne, with over 20 years of experience in monitoring, coordinating, and managing clinical trials across pharmaceutical companies and CROs. I am known for strong interpersonal and communication skills combined with a pragmatic, technically sound approach to Clinical Trial Services. I have led diverse multicentric global studies across oncology, infectious diseases, cardiovascular and other therapeutic areas, delivering high-quality results, achieving enrollment targets, and ensuring regulatory compliance. I am a proven leader with a track record of building partnerships with multicultural teams, investigational sites, and research institutes. I am seeking a leadership role within a research organization that offers challenges, learning opportunities, and professional growth, with a proactive mindset toward cost optimization.…I am Manoj Acharya, MSc Clinical Study Management, based in Melbourne, with over 20 years of experience in monitoring, coordinating, and managing clinical trials across pharmaceutical companies and CROs. I am known for strong interpersonal and communication skills combined with a pragmatic, technically sound approach to Clinical Trial Services. I have led diverse multicentric global studies across oncology, infectious diseases, cardiovascular and other therapeutic areas, delivering high-quality results, achieving enrollment targets, and ensuring regulatory compliance. I am a proven leader with a track record of building partnerships with multicultural teams, investigational sites, and research institutes. I am seeking a leadership role within a research organization that offers challenges, learning opportunities, and professional growth, with a proactive mindset toward cost optimization.

Available to hire

I am Manoj Acharya, MSc Clinical Study Management, based in Melbourne, with over 20 years of experience in monitoring, coordinating, and managing clinical trials across pharmaceutical companies and CROs. I am known for strong interpersonal and communication skills combined with a pragmatic, technically sound approach to Clinical Trial Services.

I have led diverse multicentric global studies across oncology, infectious diseases, cardiovascular and other therapeutic areas, delivering high-quality results, achieving enrollment targets, and ensuring regulatory compliance. I am a proven leader with a track record of building partnerships with multicultural teams, investigational sites, and research institutes. I am seeking a leadership role within a research organization that offers challenges, learning opportunities, and professional growth, with a proactive mindset toward cost optimization.

Skills

Presentation Design

Data Visualization

Experience Level

Presentation Design

Expert

Data Visualization

Intermediate

Language

English

Fluent

Work Experience

Country Study Operation Manager at ICON

January 1, 2024 - June 30, 2024

Permanent role with ICON – on assignment with Pfizer. Manage global studies on country level from start-up to close-out; primary point of contact with Sponsor on FSP model; liaise with internal and external stakeholders; collaborate with start-up team for Ethics and Regulatory submissions; manage Ethics Committee and Regulatory queries; prepare ICDs; conduct trainings for CRAs.

Clinical Study Manager at Smith & Nephew

September 11, 2023 - December 23, 2023

Contract role (six months). Deliver clinical research projects and utilize CTMS, eTMF, and EDC to meet milestones and quality expectations; develop Investigator Brochures, monitoring plans, clinical trial protocols, and CSR/CRF oversight; oversee site selection and monitoring; manage vendors/CROs; ensure GCP/ISO 14155 compliance.

Sr Regional Clinical Trial Manager at Docs Global, ICON

September 1, 2019 - June 30, 2023

Lead and manage the conduct of clinical trials across multiple countries in accordance with ICH-GCP and local regulations; collaborate with country leads and the Global Clinical Trial Manager for global execution; ensure quality and integrity; lead cross-functional teams; training and mentoring; site management oversight.

Sr. Clinical Research Associate (Sr. CRA) at Premier Research

November 1, 2016 - September 30, 2019

Monitor complex clinical trials; train and lead CRA I–III; schedule and conduct site visits; ensure IC/CSR accuracy, TMF/eTMF compliance, and data quality; coordinate with data management and vendors; oversee site budgets and logistics.

Sr. CRA at InVentiv Health

April 1, 2016 - September 30, 2016

Monitor clinical studies according to project standards and regulatory guidelines; perform site evaluations, initiations, interim monitoring, and close-out visits; manage site relationships and issue resolution; ensure patient safety and informed consent.

Sr. CRA at PRA Health Science

February 1, 2015 - March 31, 2016

Monitor studies according to ICH-GCP/ISO14155; site visits, data verification, and query resolution; oversee regulatory submissions and site regulatory files; ensure IMP accountability and coordination with vendor labs.

CRA at INC Research, Australia

January 1, 2013 - February 28, 2015

Monitor Phase III/Phase I–II studies; site evaluations, monitoring visits, data verification, and close-out activities; coordinate with data management, vendors, and investigators.

Clinical Study Manager at I3 Research, Australia

March 1, 2012 - January 31, 2013

Lead clinical study activities in Australia; manage start-up, site initiation, monitoring, and close-out; coordinate with cross-functional teams to ensure protocol adherence and data quality.

Clinical Study Manager at I3 Research, UK

September 1, 2010 - March 31, 2012

Manage clinical studies across multiple regions; lead country teams and ensure on-time deliverables; oversee study documentation and regulatory submissions.

Project Management at AstraZeneca, UK

November 1, 2009 - September 30, 2010

Coordinate operational aspects of global studies from design to database lock to close-out; lead and participate in study delivery and interface with clients and internal teams.

Associate Project Manager at Lambda Therapeutics Ltd

March 1, 2008 - June 30, 2009

Single point of contact for project issues; mentor and lead a team of CRAs; manage multiple studies from start-up to close-out; develop proposals and budgets; ensure SOP/ICH GCP compliance.

Sr. CRA at Chiltern (Former Omnicare)

August 1, 2007 - March 31, 2008

Lead monitoring activities; train study teams; contribute to multiple site visits and regulatory submissions; manage investigator relationships and study supplies.

CRA at Clinigene International Ltd, BIOCON

July 1, 2004 - August 31, 2007

Independently led studies, conducted site initiations, monitoring, and close-outs; coordinated ethics submissions, CRF design, and regulatory filings; managed drug accountability and feasibility.