Michelle Williams
Site Alliance and Clinical Operations Manager at CSI Medical Research Pte Ltd- Claim this Profile
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Bio
Experience
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CSI Medical Research Pte Ltd
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Singapore
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Site Alliance and Clinical Operations Manager
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Feb 2023 - Present
In this role I am working to connect the Australian and New Zealand all direct and indirect clinical research capabilities to showcase to global partners. I work with clients to understand their needs, manage team to mitigate risks and operationalise clinical trials across the ANZ and the wider ASEAN region. In addition, I work within the business development team to develop clinical trial plans from pricing and strategy into proposals for our prospective clients. In this role I am working to connect the Australian and New Zealand all direct and indirect clinical research capabilities to showcase to global partners. I work with clients to understand their needs, manage team to mitigate risks and operationalise clinical trials across the ANZ and the wider ASEAN region. In addition, I work within the business development team to develop clinical trial plans from pricing and strategy into proposals for our prospective clients.
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Apr 2020 - Jan 2023
Patient recruitment to clinical trials is becoming more challenging with more complex eligiblity criterias. This challenge has multiple dimensions within the drug development organization to the trial sites who are enrolling the patients. I build the site engagement strategy to lead our team of site partnership managers across 3 regions to connect to their institutions developing relationships centered on an innovative method of selecting the most suitable trial studies and to identify patients ready to be enrolled. I bring together talented and enthusiastic individuals from our organization and from the trial sites to work collaboratively to leverage innovations that can enable the acceleration of patient recruitment without compromising patient care. Show less
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Nov 2019 - Jan 2023
Working collaboratively with countries within the APAC- EMEA region to deliver on project plans. Setting project expectations, learning, identifying risks and to planning to mitigate risks to ensure delivery. Identify opportunities to improve efficiencies and providing project teams with the local perspective to ensure plans are logistically viable and sustainable to minimise implementation issues.
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Jan 2017 - Nov 2019
Working on high profile products to deliver data to support positive health outcomes for patients throughout Australia and New Zealand. I work cross functionally to deliver innovative solutions to drive team and health service providers to deliver quality patient data. To ensure quality data is collected, I am responsible for selecting the health care providers and manage across all teams internal and external to work as one team to deliver data within timelines. I manage stakeholder expectations and ensure transparency across the business from management, core team, health care providers and other business units to ensure expectations are clear. I drive efficiencies within each project to ensure the best outcomes. Show less
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Dec 2016 - Dec 2017
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May 2014 - Nov 2016
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Novotech
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Australia
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Biotechnology Research
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700 & Above Employee
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Clinical Research Associate
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Oct 2011 - Apr 2014
Working in teams from 7 to 20 team members to select, initiate, monitor and provide solutions for pharmaceutical and biotech companies conducting trials in Australia. Role included the following: • Conduct feasibility assessments of sites for potential clinical trials • Conduct site selection and initiation visits within Australia and New Zealand • Feasibility and start up processes (Site ethics submission, regulatory submission, negotiation of budgets and contracts, review and submission of informed consent) • In-house and on-site monitoring (interim to close out), activities for multiple hospital and private clinic sites in accordance with designated project assignment • Meeting deadlines for database lock of site data for interim or final analysis • Mentor and train junior CRAs Experience in neurology, oncology, nephrology, dermatology and infectious diseases. Opportunity to mentor and train junior CRAs by providing on the job training. Show less
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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SSU Associate Specialist
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Sep 2010 - Oct 2011
• Design feasibility questionnaires to assess the patient recruitment numbers to provide global project team and Sponsor in particularly working closely with pharmaceutical team opportunities • Review feasibility data from medical officers to accurately assess whether particular study opportunities were feasible in ANZ and present this data to proposal meetings • Accountable for making recommendations for Quintiles commitments for future studies in terms of recruitment rate, timelines and screen failure rates. These were from data mining internal and external clinical trial databases. • Liaise with internal and external customers globally to coordinate the collection and delivery of data • Site start up activities from site selection to initiation • Advised global study teams to advise on the ethics committee landscape within Australia • Prepare, review and negotiate budgets and contracts with sites and Sponsor Show less
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Vascular Biology Research Centre, Westmead Hospital
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The University Of Sydney, New South Wales, Australia
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Transforming innovative biotechnology translated into data driven research outcomes
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2006 - 2010
Postgraduate research: Discovered that the activation of platelets caused changes in monocytes to take on characteristics of a smooth muscle cells that are pivotal in sustaining atherosclerotic plaque encapsulation to reduce ruptures causing devastating effects including heart attacks and strokes. Postgraduate research: Discovered that the activation of platelets caused changes in monocytes to take on characteristics of a smooth muscle cells that are pivotal in sustaining atherosclerotic plaque encapsulation to reduce ruptures causing devastating effects including heart attacks and strokes.
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Education
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University of Sydney
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology -
University of Sydney
Bachelor of Medical Science (Hons)