Ben Edwards Email & Phone Number

Firle, South Australia, Au

Firle, South Australia, Au

Morrisville, Nc, Us

Morrisville, North Carolina, Us

Syneos 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™.

- 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

Port Adelaide, Au

My 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.

Port 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

Port 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

Port Adelaide, Au

Senior 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

Durham, 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

Thebarton, 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.

- 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.

Master Of Business Administration (Mba)

Bachelor Of Science, Biology

Education record