Job Description:

Excellent benefits including salary packaging
Fitzroy location
Challenging and rewarding work environment
Permanent (38 hours per week)

About the Role

You will be responsible for establishing and comprehensiveclinicaltrials service to international and domestic from company sponsored drug trialsbloodand tissue banks role also has responsibility for other corporate/contractpathology work.

• Driving the commercial success of clinical trialscontract pathologybusiness

• Lead the development and implementation of a clinical trials operational plan for Pathology aligning with SVHMs research growthobjectivesand expanding external trial partnerships.

• Identifynew opportunities to increase the profitability of thebusiness

Classifications for this position will range from classification range JB21-JB24 ($126079- $138928 per annum).

Your Contribution
Relevant tertiary qualifications in Medical Science Health Science or Allied Health

Knowledge of clinical trials andscientific understanding of pathology and laboratory operations
Experience in client management and businessdevelopment
Minimum 5 years research science clinicaltrialor relatedexperience

Excellent knowledge of project management data managementlogisticsmanagementand qualitymanagement

What we Offer
A focus on wellbeing initiatives with regular events and programs
A healthy work/life balance encouraged. Full time employment comes with a monthly Accrued Day Off (additional day off per month!)
Ability to join Fitness Passport - Your pass to an extensive choice of fitness facilities
Salary Packaging Increase your take home pay!
In the heart of Fitzroy CBD at our doorstep close to some of Melbournes best cafes public transport and lots of carparks
Discounts and Promotions always available through our Foundation

About Pathology

St Vincents Pathology(SVP)provides diagnostic testing to both inpatients of St Vincents Private Hospitalslocatedin Fitzroy East Melbourne and Kew St Vincents Public Hospital Fitzroy as well as servicing privately referred patients from over Pathology Collection Centreslocatedacross Metropolitan Vincents Pathology is a member of a multidisciplinary health care team which delivers care in a patient focused manner.

The Pathology Clinical Trials Unitoperateswithinthe St Vincents Pathologydepartment.

Working at St Vincents
St Vincents Hospital Melbourne (SVHM) is a leading teaching research and tertiary health service. SVHM provides a diverse range of adult clinical services and is driven by values of Compassion Justice Integrity and Excellence.

Application

Please attach your resume and cover letter to your application.

Shortlisting for this position will commence immediately. We encourage you to apply promptly as the advertisement may close early should a suitable applicant be sourced.
We encourage applications from people of all backgrounds and abilities. Inclusion is essential to our mission and diversity reflects the community we serve.
Please visit our website for further information regarding our Aboriginal and Torres Strait Islander Employment at SVHM.
SVHA has a duty of care under work health and safety legislation to eliminate and/or control the risk of transmission of vaccine preventable diseases in healthcare settings. You may therefore be required to undergo mandatory immunisations/vaccinations (including flu vaccinations).
This position is subject to a Victorian government direction regarding vaccination against COVID-19. Successful applicants must meet these vaccination requirements. Please contact us if you would like to know more.

The primary responsibility of this position is to establish and manage a comprehensive clinical trials service covering phase 1-4 research programs to international and domestic organisations. The trials will range from company sponsored drug trials blood and tissue banks and investigatorinitiated research. The role also has responsibility for other corporate/contract pathology work.

The Clinical Trials Manager will manage all the activities of the Pathology Clinical Trials and will be responsible for making it a profitable business unit.

PRIMARY DUTIES:

• Driving the commercial success of clinical trials contract pathology business;
• Lead the development and implementation of a clinical trials operational plan for Pathology aligning with SVHMs research growth objectives and expanding external trial partnerships.
• Prepare the Clinical Trial Business Plan and monitor the performance against business plan objectives;
• Achieve budgeted milestones and established targets;
• Implement KPIs to monitor performance against objectives;
• Identify new opportunities to increase the profitability of the business;
• Determine appropriate fee structure;
• Prepare quotations and negotiate contracts for clinical trials/contract pathology;
• Overseeing monthly billing of clinical trials/contract pathology;
• Manage the day-to-day operations of the Pathology Clinical Trials portfolio and other contracted pathology ensuring timely and high-quality delivery of services across study phases (start-up conduct close-out).
• Optimising workflows managing and maintaining the currency of all procedures;
• Liaise with SVP and SVHM staff to ensure effective information flow and to facilitate operations;
• Liaise with relevant staff at SydPath Clinical Trials regarding jointly performed contract work;
• Manage and oversee trouble-shooting where it relates to clinical trials/corporate pathology;
• Ensure full compliance with regulatory requirements including but not limited to ISO 15189 and Good Clinical Practice (GCP) National Clinical Trials Governance Framework (NCTGF) SVHM policies and all regulatory and sponsor requirements.
• Ensure compliance with client and relevant regulatory requirements; support customer audits and inspections as required.
• Oversee the investigation and management of clinical trial-related non-conformances and complaints ensuring documentation within the Quality Management System completion of corrective actions and preparation of investigation reports where required.
• Identify and implement process improvements to streamline trial activation data management and sample logistics workflows. Contribute to digital innovation and system integration initiatives.
• Maintain costs and optimise prices through negotiating with vendors;
• Manage order process and stocktakes for supplies utilised for clinical trials;
• Prepare business proposals to support specific requests for additional resources equipment development software;
• Provide regular reports to the Pathology Operations Manager.

General

• Perform the duties of the position to the best of their ability and to a standard acceptable to SVHM
• Comply with and ensure all those in the area they manage comply with all SVHM requirements policies procedures by laws and directions

• Treat others with respect and always behave professionally and in accordance with the SVHM Code of Conduct
• Only access confidential information held by SVHM when this is necessary for business purposes maintaining the confidentiality of that information once accessed
• Participate in the annual SVHM performance review process
• Display adaptability and flexibility to meet the changing operational needs of the business
• Comply with applicable Enterprise Bargaining Agreement provisions
• Display a willingness to develop self and seek to improve performance
• Maintain skills and knowledge necessary to safely and skilfully undertake duties
• Take personal responsibility for the quality and safety of work performed
• Recognise the relationship between clinical and non-clinical functions in the achievement of optimal safety and quality care
• Take all necessary care and precautions in the performance of duties
• Participate in risk management and continuous quality improvement activities as part of day-to-day work

Health and Safety

• Attend general hospital orientation within 3 months of commencement
• Ensure all health and safety related policies procedures and directions are complied with in the area they manage
• Protect the health and safety of self and others complying with all health and safety related policies procedures and directions
• Report incidents and accidents and collaborate with management to resolve safety issues
• Complete required Fire and Emergency Training annually

• Complete required Workplace Culture and Equity Training annually

• Ensure all in the area they manage undertake annual Fire and Emergency Training and comply with fire and emergency procedures
• Ensure all those in the area they manage treat others with respect behaving professionally and in accordance with the SVHM Code of Conduct and undertaking annual Workplace Culture and Equity Training
• Conduct regular safety audits with Health and Safety Representatives and implement required improvements
• Minimise WorkCover costs by actively assisting the return to work of any employee injured in the area they manage.
• As required comply with fit-testing and PPE requirements
• Participate in reporting and analysis of safety and quality data including risks or hazards
• Report any hazards near misses and incidents (regardless of whether an injury occurred or not) into Riskman;
• Identify and report any variance to expected standard and minimising the risk of adverse outcomes

Human Resource Management

• Ensure that workforce planning is regularly undertaken and implemented to provide for the ongoing resource needs of the area they manage.
• Ensure recruitment and working practices comply with applicable Enterprise Bargaining Agreement and cost effectively support delivery of quality service.
• Ensure new employees are properly inducted to their local work environment and attend the General Hospital Orientation program.
• Ensure all those who work in the area managed undertake an annual performance review and are developed to reach their full potential.
• Maintaining skills and knowledge necessary to safely and skilfully undertake duties.
• Ensure leave is rostered fairly and that employees in the area managed regularly take leave and do not accumulate excessive leave except where a plan is in place as to when that leave will be taken
• Actively manage individual and team performance to maximise performance and minimise workplace problems and conflict
• Continuously seek individual and team improvement and take responsibility for the introduction of any changes required to bring about such improvements
• Staff management including: recruitment staff training effective supervision and rostering; maintain

staff records; manage staff leave; regular performance appraisals; regular staff meetings and continuing education

Financial management

• Participate in the development of the annual budget for Clinical Trials as required
• Monitor budget on monthly basis;
• Monitoring revenue on monthly basis;

• Monitor FTE and expenditure to ensure spending remains within budget allocation
• Ensure decision making remains within delegated authority

Relevant Tertiary Qualifications.

Bachelors degree in one of the following:

• Medical Laboratory Science
• Biomedical Science
• Science (Biological Medical or Health Sciences)
• Health Science or Allied Health (relevant to pathology or clinical research)
  

• Knowledge of clinical trials and scientific understanding of pathology and laboratory operations.
• Experience in client management and business development.
• Minimum 5 years research science clinical trial or related experience.
• Demonstrated understanding of relevant quality and regulatory requirements including GCP and ISO 15189 with working knowledge of applicable FDA codes of practice (e.g. 21 CFR Part 11) and GxP principles for industry-sponsored clinical research;
• Excellent knowledge of project management data management logistics management and quality management;
• Ability to identify and respond rapidly to new technology and IT requirements;
• Ability to identify and develop marketing and promotional materials
  

• Previous experience in using Q-pulse or other quality data management system
• Experience using Kestral Pathology Laboratory System

Closing Date:

Reconciliation Action Plan:

At St Vincents we acknowledge the importance of creating a work environment that is welcoming safe equitable and inclusive for Aboriginal and/or Torres Strait Islander Employees. As part of our Commitment to Reconciliation and Closing the Gap in employment related outcomes we encourage applications from Aboriginal and Torres Strait Islander Peoples.

For further information visit https:// or get in contact at

View Reconciliation Action Plan

Code of Conduct:

View Code of Conduct