Ben Edwards work email
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With 25+ years of industry experience Ben has gained a depth of knowledge that has allowedhim to successfully support clients internationally and in the Asia Pacific region to gain marketregistration for their new pharmaceutical drug products. This includes product approvals by the US FDA, in Europe, the Japan PMDA and Chinese CFDA. Ben is also an accomplished leader of teams with significant experience in directing large multi-function teams across all continents. This includes providing project specific oversight, guiding fact based decision making specifically designed around risk minimization and delivering value to clients as well as ensuring that resources across the region are managed tightly according to the project needs.The Asia Pacific market place for clinical trials is diverse and complex. Ben has had significantexperience managing clinical programs in the Asia Pacific region including India, Japan, SouthEast Asia, China and Australia/New Zealand. In addition to this Asia Pacific experience Benhas directed international teams in Europe, USA and Latin America and has successfullyapplied his leadership skills and business acumen in these international settings.Specialties: Ophthalmology - Age-related Macular Degeneration, Diabetic Macular Edema, Dry Eye Disease, Retinal Vein OcclusionCardiovascularRare DiseasesChina Japan South East AsiaClinical ResearchProject ManagementCustomer Relationship ManagementClinical Operations ManagementLean Six-Sigma Green BeltFDA Inspection Experience; andClinical Team Leader.
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Chief Operating OfficerAvance Clinical Apr 2023 - PresentFirle, South Australia, Au
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Chief Strategy OfficerAvance Clinical Jul 2019 - Apr 2023Firle, South Australia, Au
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Managing DirectorAstrx Clinical Research May 2019 - Jul 2019
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Executive DirectorSyneos Health Jan 2019 - May 2019Morrisville, Nc, Us -
Senior Project DirectorSyneos Health Clinical Solutions (Previously Inc Research/Inventiv Health) Jan 2018 - Dec 2018Morrisville, North Carolina, UsSyneos Health™ is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies — INC Research and inVentiv Health — we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. In short, we are shortening the distance from lab to life™. -
Senior Project ManagerIncresearch Australia (Formerly Trident Clinical Research) Jul 2008 - Apr 2012- Provision of senior project management oversight for allocated projects.- Provision of advice, guidance and training to assigned Project Managers on budgetary control and INCResearch (Trident) project management tracking systems.- Provision of orientation and ongoing training for Project Managers.- Project management duties as listed below.- Line management ResponsibilitesTrial involvement:• Phase III Acute Coronary Syndromes• Phase III Endocrinology• Phase IV Influenza Vaccine (2009) • Phase IV Influenza Vaccine (2008)• Phase III Sleep Maintenance Insomnia (2 studies)• Phase III Rheumatology• Phase III Prostate Cancer• Phase II Irritable Bowel Syndrome
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Associate Clinical Operations ManagerTrident Clinical Research Jul 2010 - Oct 2011Port Adelaide, AuMy role as Associate Clinical Operations Manager at Trident Clinical Research involves the following:- Collaborating with Clinical Operations Manager (COM) in relation to recruitment of new Clinical Operations staff.- Management of clinical staff resources under direction of COM.- Coordination of quality control procedures including co-monitoring activities for Clinical Operations as directed by the COM.- Provision of assistance with customer relationships.- Assisting the COM with management of orientation. activities for new staff and coordination of developmental programs for Clinical Operations staff; and- Provision of assistance with writing and review of Standard Operating Procedures and Policies. -
Clinical Team Leader & Senior Project ManagerTrident Clinical Research Jul 2008 - Oct 2011Port Adelaide, Au- Provision of senior project management oversight for allocated projects.- Provision of advice, guidance and training to assigned Project Managers on budgetary control and Trident project management tracking systems.- Provision of orientation and ongoing training for Project Managers.- Project management duties as listed below.- Line management ResponsibilitesTrial involvement:• Phase III Acute Coronary Syndromes • Phase IV Influenza Vaccine (2009) • Phase IV Influenza Vaccine (2008)• Phase III Sleep Maintenance Insomnia (2 studies)• Phase III Rheumatology• Phase III Prostate Cancer• Phase II Irritable Bowel Syndrome
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Project ManagerTrident Clinical Research Mar 2007 - Jul 2008Port Adelaide, Au- Provision of project management services for clinical projects to ensure that projects are completed within defined scope, time and cost constraints. This includes supervision of project teams, coordination of project logistics, tracking of timelines and budgets, coordination of client communications.Trial involvement:• Phase IV Influenza Vaccine (2008)• Phase III Sleep Maintenance Insomnia (2 studies)• Phase III Rheumatology• Phase III Prostate Cancer• Phase II Irritable Bowel Syndrome
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Senior Clinical Research AssociateTrident Clinical Research Feb 2005 - Mar 2007Port Adelaide, AuSenior Clinical Research Associate- Provision of start-up and monitoring services for clinical projects. This includes pre-trial activities, site initiation, ongoing monitoring and management of trial sites, site closure activities, site follow-up activities and generation of site visit reports.- Provision of consultative duties, as required. This included development of trial protocols, development of Case Report Forms, and selected medical writing tasks.- Provision of mentoring role to internal clinical staff, as appropriate.-Assistance with writing of Standard Operating Procedures.Provision of Senior Clinical Research Associate services provided for the following clinical trials:• Phase III Sleep Maintenance Insomnia• Phase III Rheumatology• Phase III Crohns• Phase III Prostate Cancer• Phase I Healthy Volunteers• Phase I Rheumatology• Phase II Irritable Bowel Syndrome
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Clinical Research AssociateQuintiles Jul 2002 - Feb 2005Durham, North Carolina, Us- responsible for all aspects of clinical trial monitoring:• Trial site selection and trial feasibility assessments• Ethics and Regulatory submissions• Trial site initiation• Trial monitoring• Drug accountability• Management of Serious Adverse Events• Trial closeout and archivingProvision of Clinical Research Associate services provided for the following clinical trials:• Gastric Cancer Trial • Lung Cancer Trial• Rheumatoid arthritis Trial• Hepatitis B Trial -
Clinical Trials AssistantGropep Bioreagents Pty Ltd Jun 2000 - May 2002Thebarton, South Australia, Au- conduct clinical trials in accordance with recognised international standards of Good Clinical Practice (ICH-GCP), the regulatory guidelines and company standard operating procedures- support Clinical Research Associates in co-ordinating activities for GroPep-sponsored Phase I and II clinical trials including;• Co-monitoring visits and monitoring visit reports;• Liaising with investigational site staff;• Ethics and regulatory submissions;• Set up and maintenance of clinical trial project files;• Co-ordinating the shipment of investigational product to trial sites;• Maintaining GroPep’s adverse event/safety databases. -
Technical OfficerChild Health Research Institute, Women’S And Children’S Hospital Dec 1995 - May 2000- Function was to provide technical support within a pre-clinical research and development team for a ‘wound healing’ medicine in a hospital laboratory setting. - Conducted pre-clinical research activities utilising animal models- Completion of assays to establish results for pre-clinical trials.
Ben Edwards Skills
Ben Edwards Education Details
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University Of AdelaideMaster Of Business Administration (Mba) -
University Of South AustraliaBiology
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Eynesbury College
Frequently Asked Questions about Ben Edwards
What company does Ben Edwards work for?
Ben Edwards works for Avance Clinical
What is Ben Edwards's role at the current company?
Ben Edwards's current role is Chief Operating Officer at Avance Clinical.
What is Ben Edwards's email address?
Ben Edwards's email address is be****@****rch.com
What schools did Ben Edwards attend?
Ben Edwards attended University Of Adelaide, University Of South Australia, Eynesbury College.
What skills is Ben Edwards known for?
Ben Edwards has skills like Clinical Development, Clinical Trials, Clinical Monitoring, Ctms, Clinical Research, Ich Gcp, Regulatory Submissions, Protocol, Cro, Clinical Operations, Gcp, Good Clinical Practice.
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