Clinical Trials Project Manager Reports to
Burcu Vachan Oncology Program Manager NHMRC Clinical Trials Centre
Organisational area
NHMRC Clinical Trials Centre Faculty of Medicine and Health
Position summary
The Clinical Trials Project Managers are responsible for the overall management, coordination and administration of projects or allocated clinical trials relevant to specific research areas, covering oncology or Cardiovascular/Diabetes.
The team of Project Managers work on the portfolio of studies in their respective research/disease area working with their teams of specialised staff working as Study Coordinators, Data Managers, Study Monitors and Clinical Trial Assistants in the tumour streams of Gastro-intestinal, Gynaecological, Brain, Lung and Urogenital research, cardiovascular disease & diabetes. Project Managers are involved in development or operational activities depending on education and training, experience and opportunities.
The activities range from: • negotiating budgets and resource requirements for large scale international multi-site studies • working with international regional coordinating centres and vendors for CRO and CMO services • funding applications and reporting • scientific/research/operations committee support including Trial Management Committees • milestone and financial reporting • local and international HREC and governance (and equivalent) submissions • high level project management • oversight of trial operations including data management and onsite and remote monitoring • training and development of more junior team members.
The role will involve working with other senior staff at the CTC e.g. clinical investigators and biostatisticians for protocol development and with interim and final analyses and poster and manuscript publications. The role may also involve the line management of more junior staff.
More information about the specific role requirements can be found in the position description at the end of this document.
Location
The Chris O’Brien Lifehouse Camperdown/Darlington Campus
Type of appointment
Full time, fixed term for 2 years
Salary
Base salary $103K - $116K p.a. plus generous superannuation benefits
How to apply
All applications must be submitted online via the University of Sydney careers website. Visit sydney.edu.au/recruitment and search by reference number 1543/0818F for more information and to apply.
For further information
For information on position responsibilities and requirements, please see the position description attached at the end of this document.
Intending applicants are welcome to seek further information about the position from:
Burcu Vachan Oncology Program Manager NHMRC Clinical Trials Centre [email protected]
For enquiries regarding the recruitment process, please contact:
Linden Joseph Recruitment Consultant 8627 1208 [email protected] About the University of Sydney
The University of Sydney is a leading, comprehensive Our campuses research and teaching university. We are committed to harnessing the transformative power of education to Located close to the heart of Australia’s largest and most foster greater knowledge and a better understanding of international city, our Camperdown/Darlington Campus the world and its people. features a mixture of iconic Gothic-revival buildings and state of-the-art teaching, research and student support facilities. We are highly influential in shaping Australia’s national The University also has an extensive footprint throughout and international agenda, and delivering solutions to the Sydney. Some faculties are based in Camperdown/ challenges facing society. We achieve this through critical Darlington but have facilities elsewhere. For example, analysis, intellectual leadership and active contribution to Veterinary Science and Agriculture & Environment have public debate. farms and research units at the Camden Campus, while the Faculty of Medicine and Health has clinical schools in Our primary objective is to create and sustain a university hospitals across the city and in rural NSW with very close in which, for the benefit of both Australia and the wider cooperative links and affiliations with a range of independent world, the brightest researchers and the most promising medical research institutes. students, whatever their social or cultural background, Other faculties and schools have their own dedicated can thrive and realise their full potential. campuses, such as the Sydney Conservatorium of Music in This central purpose underpins our strategic goals. It the central city, Sydney Dental School in Surry Hills and challenges us to develop and support a community of Westmead, Health Sciences at Lidcombe, and Sydney scholars, where interdisciplinary research can flourish and Nursing School at Mallett Street, Camperdown. where the student experience is enriched. Our researchers and students have access to excellent library resources. These will soon be enhanced by a range To learn more about our strategic objectives, including of new technology-enabled learning environments, thanks to how we developed those goals and our progress towards a project currently underway on the Camperdown/Darlington achieving them, visit sydney.edu.au/strategy/about Campus.
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The University of Sydney is recognised as one of the best universities in the world, with a breadth and depth of disciplinary excellent unequalled by any other Australian university.
Careers website: sydney.edu.au/recruitment Our research, all of which is ranked at world standard or above (ERA 2015), is driven by the big picture and aims to Home page: sydney.edu.au solve the most important problems and the most exciting Organisational structure: sydney.edu.au/about-us/ new challenges facing society. governance-and-structure/organisational-structure
The University of Sydney invests in research excellence. Annual Report: sydney.edu.au/about-us/ Initiatives that contribute to outstanding research vision-and-values/annual-report outcomes are key to our University strategy and are News: sydney.edu.au/news-opinion/news being supported by an unprecedented investment in our research activities. Statistical snapshot 2017
For more information about our research and its impact, visit sydney.edu.au/research Enrolments, total 67,790
Our teaching Enrolments, international 24,844
The University of Sydney attracts highly talented Staff (full-time equivalent) 8307.4 undergraduate and postgraduate students, drawn by our Faculties and University schools 12 comprehensive range of quality degrees and a strong track record for postgraduate researchprograms. Research centres and institutes 90
Student:Staff ratio 16:1 Our students study alongside top researchers and, in some cases, contribute to their research. We expect them ARC Centres of Excellence 11 to excel and challenge them to succeed as leaders in Cooperative Research Centres (CRC) 13 whatever career field theychoose. HERDC researchincome (2016) $331.55 million
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At the University of Sydney, we attract the most vibrant thinkers to form a community dedicated to the pursuit of transformative education and research.
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If you want to engage with brilliant minds, are willing to push boundaries, and believe in making a positive difference, you’ve come to the right place. Our people come from all cultures and backgrounds and enjoy a true sense of community and belonging.
We recognise that our talented staff are invaluable and we support them to achieve their career ambitions. Using our outstanding local and global networks, we can offer flexibility, responsibility, personal and professional development, and much more.
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We welcome open minds, curiosity, and a readiness to tackle big questions – and we reward it accordingly. Our people are part of an exciting environment where development is encouraged and intellectual pursuits foster a sense of purpose and confidence.
In addition to a competitive base salary, we offer a wide variety of financial and non- financial benefits to our staff.
These include: − working arrangements which assist staff in managing their work and personal/family responsibilities and provide flexibility in meeting business needs. − family-friendly working hours − generous leave entitlements − a University contribution of up to 17% of base salary to your superannuation (pension) fund after 12 months of service − opportunities for tax-efficient salary packaging, including motor vehicles, laptops and additional personal contributions to your superannuation fund − a variety of training and development opportunities − exceptional health and wellbeing services, including sports and fitness centres, medical clinics and free counselling via the Employee Assistance Program − University Parents Network which offers support to parents throughout the University − on-campus parking and convenient transport services − contribution to professional membership fees − an entirely free Staff Benefits Program providing online and retail discounts across an extensive range of goods and services − access to the cultural life on campus which includes our museums and art galleries; music and theatre at the Conservatorium of Music and Seymour Centre; and Sydney Ideas which is the University’s premier public lecture series program that aims to bring some of Sydney’s, Australia’s, and the world’s leading thinkers to the wider Sydney community.
Join our community and we’ll help fulfil your career ambitions and transform your life.
About the new Faculty of Medicine and Health
The new University of Sydney Faculty of Medicine and Health − The redevelopment of the Westmead site will form one includes the following schools: of Australia’s largest multidisciplinary clinical service − Sydney Dental School and health research and education campuses. This will encompass Westmead Hospital (including its Dental − Sydney Medical School Hospital), the Westmead Clinical School, the Westmead − Sydney Nursing School Children’s Hospital and the Children’s Hospital Clinical − Sydney Pharmacy School School, and the Sydney Dental School, as well as the Westmead Medical Research Institute and the − School of Medical Sciences Children’s Medical Research Institute. − Sydney School of Public Health − The development of the Health Precinct on the western The Faculty of Health Sciences will join the Faculty of edge of the University’s Camperdown campus. This Medicine and Health as a School at a later date. will allow the schools of Nursing, Health Sciences, and components of Medicine, Pharmacy and Dentistry to be It also includes ten clinical schools comprising seven co-located. metropolitan and three rural clinical schools on key campuses at Broken Hill, Dubbo & Orange, and in the Northern Rivers. Sydney Dental School
The new faculty has The Sydney Dental School is ranked amongst the top approximately 1300 academic dental schools globally and is one of the largest dental staff and 950 professional schools in Australia. It is housed within the Sydney Dental and technical staff with a Hospital at Surry Hills and the Westmead Centre for Oral total annual budget around Health at Westmead Hospital with outreach across NSW. $620m. Current student The school’s mission is to “put the mouth into health” to enrolments in the five improve the health and wellbeing of our communities. This faculties is around 13,500, integration of oral and systemic health is being achieved including approximately 1920 by strategies to modify dentistry’s research and education research students, 6055 programs and to strengthen government, private, postgraduate coursework corporate and other health disciplinepartnerships. students and 5600 undergraduate students. The school offers a four-year graduate-entry dentistry Category 1 research income program the Doctor of Dental Medicine and a three in 2015 was in excess of $94m, with total research income of year Bachelor of Oral Health. The school also offers a approximately $189m. comprehensive, suite of postgraduate programs and continuing education designed to produce specialist Major initiatives within the University and in partnerships practitioners across a wide range of disciplines. It has a across the health system provide exciting opportunities rigorous research training program to produce research to exploit the inter-professional and inter-disciplinary scholars of international standing. collaborations that will form in the new faculty. The school has several established research collaborations
These initiatives include: with international universities located in China, France, Japan, Thailand and the USA, and also attracts a − The establishment of Sydney Health Partners, an sizeable applicant pool from abroad for entry into both NHMRC Advanced Health Research & Translation Centre undergraduate and postgraduate programs. formed by Sydney, Northern Sydney and Western Sydney Local Health Districts, The Children’s Hospitals Network (Westmead) and the University of Sydney. The goal of Sydney Health Partners is to promote, support and facilitate collaborative research involving the University and the health service, in order to foster research translation leading to improved health outcomes.
About the new Faculty of Medicine and Health
Sydney Medical School With major research themes in cancer, chronic disease and ageing, infection and immunity, injury and acute Sydney Medical School, ranked as 15th in the world (QS illness and mental health, the school’s mission is subject), is the oldest medical school in Australia. It was to be known internationally for a collaborative and formed in the 1850s. It accommodates 1200 medical interdisciplinary approach to achieving excellence in students undertaking a four-year graduate-entry Doctor of health and health care. Medicine program, more than 1300 postgraduate students undertaking a wide range of master’s degree, graduate There are approximately 1200 undergraduate, 700 diploma and graduate certificate courses, and almost 1400 postgraduate coursework and 75 higher degree research students undertaking research degrees. students. Committed to inter-professional learning and collaborative practice, courses reflect the changing needs Clinical Schools of health care. Students are taught by leading academics, clinicians and researchers who are part of the nursing and In addition to teaching and research facilities on the health care community. Camperdown and Westmead campuses, the Faculty of Medicine and Health has seven metropolitan clinical schools Sydney Pharmacy School and three rural clinical schools. Pharmacy at the University of Sydney began in 1899. − Central Clinical School − Children’s Hospital Westmead Clinical School In the 1990s the program underwent a number of changes, − Concord Clinical School including the introduction of courses in pharmacy practice and by 2001 there was the first graduation − Nepean Clinical School of students enrolled in the four year undergraduate − Northern Clinical School Bachelor of Pharmacy. Currently there are approximately − Sydney Adventist Hospital Clinical School 1400 students enrolled in pharmacy courses including the Bachelor of Pharmacy, Bachelor of Pharmacy and − Westmead Clinical School Management, Graduate Certificate in Pharmacy Practice − Rural Clinical School (Dubbo/Orange) and Master of Pharmacy. − Rural Clinical School (Broken Hill) Similarly, with over 100 higher degree research students, − Rural Clinical School (Northern Rivers) the University has the largest postgraduate research program in pharmacy in Australia. The faculty has many These clinical schools are now formally recognised as collaborative research projects with other faculties, organisational units of the new faculty and they are led by teaching hospitals, research institutes and the a head of clinical school reporting to the Deputy Executive pharmaceutical industry. Dean (Health and Community).
Research in pharmacy is via five research themes of The clinical schools have an extensive research program cancer, cardiovascular and diabetes, health services and which ranges from the molecular basis of disease to patient safety, mental health, respiratory disease and also clinical medicine and public health. Research is focused covers a broad spectrum of pharmaceutical and clinical on six major themes – cancer; infectious diseases and sciences, including drug development, formulation and immunology; neurosciences and mental health; obesity, delivery; and patient-centered pharmacy and health diabetes and cardiovascular disease; healthy ageing; and services delivery and research. reproductive, maternal and child health.
Sydney Nursing School
As one of the top QS (subject) ranked nursing schools in Australia, Sydney Nursing School strives to sustain a vibrant, respectful environment in which staff and students collaboratively engage in quality nursing and midwifery education and research that impacts on national and international policy and practice to improve the health of all people and their communities.
About the new Faculty of Medicine and Health
School of Medical Sciences Health Sciences
The School of Medical Sciences teaches a range of The Faculty of Health Sciences is ranked 33rd in the Times discipline areas to medical and dental students. The Higher Education World University Rankings for clinical, school teaches extensively in the Bachelor of Medical pre-clinical and health. Science as well as in many discipline-based courses in the Bachelor of Science (Faculty of Science).The school The faculty has more than 4300 enrolments in seven allied also teaches in the Bachelor of Pharmacy degree and to a health disciplines. The faculty’s researchers are global range of health sciencestudents. leaders in ageing, disability, exercise, physical and mental health and wellbeing, cancer diagnosis and survivorship, The school was formed in 2001 and currently incorporates rehabilitation, speech and communication disorders, and the disciplines of pathology, pharmacology, physiology, arthritis and musculoskeletal conditions. and anatomy and histology. In 2006, the discipline of biomedical science in the Faculty of Health Sciences at The faculty is focused on some of the major challenges the Cumberland Campus was also incorporated into the confronting the Australian health care system including school. those groups living in rural and remote areas, people of Aboriginal and Torres Strait Islander descent, people who Apart from its teaching activities, the school is one of are socially and financially disadvantaged, and people with the most research-intensive in the University and a major disabilities. player in Australian and international biomedical research across a range of fields. Graduates include CEOs of Commonwealth authorities and hospitals, founders and directors of leading NGOs, Sydney School of Public Health government officials and presidents of professional associations. The faculty has a network of over 28,000 The School of Public Health is Australia’s first established highly engaged alumni from across the globe. and leading school of public health with a community of academics, educators, staff, research groups and The Faculty of Health Sciences will join the new Faculty of centres that offer a wide range of education and research Medicine and Health at a future date and remains as a opportunities for students. Today the school has more faculty until further notice. Once part of the new faculty it than 300 staff and over 1000 students. will be known as the Sydney School of Health School
The school’s vision is for a global community where everyone’s needs for good health and wellbeing are met. This vision extends to those with the greatest need, who would benefit most from improved health and reduced inequalities. The school actualises this position by providing high quality, accessible education, conducting outstanding, high impact research and working in partnership to translate knowledge into policy, action and innovation.
Our staff have an outstanding reputation for high quality teaching and research. Our academics are leaders in their field - in areas like tobacco control, chronic disease prevention, healthy ageing, infectious disease, population health metrics and physical activity. They are working with leading institutions such as the World Health Organisation, Gates Foundation, and Australian government at the local, state and federal level to bring the benefits of public health policy and practice to the people who need it most.
POSITION DESCRIPTION
POSITION DETAILS POSITION TITLE Associate Oncology Program Manager
SCHOOL / NHMRC Clinical Trials Centre-Clinical Trial Operations DEPARTMENT Oncology trials/ Neonatal trials/ Cardiovascular Trials
FACULTY / PSU Sydney Medical School
CLASSIFICATION HEO8
REPORTS TO Associate Oncology Program Manager
CLASSIFICATION CAT12091a CLASSIFICATION 23 June 2017 CODE DATE
PRIMARY FUNCTION The Associate Oncology Program Manager is responsible for the overall management, co-ordination and administration of a project or allocated clinical trials relevant to a specific research area covering oncology (APM), neonatal or cardiovascular disease.
This involves working in collaboration with other Associate Program Managers to manage a group of trial activities or managing a large single trial or study from protocol development, ethics and regulatory requirements, and concept development work for sub-studies.
The Associate Oncology Program Manager is also responsible for the development of systems, forms design and other study related materials to be used by CTC and the trial sites to ensure compliance with the protocol and regulatory requirements.
OVERVIEW OF THE SCHOOL / DEPARTMENT AND POSITION CONTEXT The NHMRC Clinical Trials Centre at the University of Sydney conducts large multicentre investigator-initiated clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others. Clinical trials conducted by academic research centres adopt different models for managing and conducting clinical trials, which differs from the pharmaceutical industry models and contract research organisations.
These roles are responsible for either a number of clinical trials or a large single study by providing high level expertise in the concept development stage by assisting trial investigators, the CTC and collaborative groups (where relevant) to develop and pursue external funding and resourcing opportunities including the development of grant proposals.
They also provide high level expertise in supporting the Senior Trial Co-Ordinators who are responsible for working on or co-ordinating large multicentre investigator-initiated clinical trials, co-ordinating stand alone clinical trials or participates in trials that are co-ordinated by other national and international collaborative trial groups.
They manage the budget, staffing, and resourcing of the trial/s within their allocated trial group, and participate on various committees associated with the collaborative or stakeholder groups. They provide high level strategic and advisory support to the Senior Trial co-ordinators who are responsible for the day-to-day implementation and co-ordination of clinical trials.
They also mentor and professionally develop staff who are progressing their clinical trial careers, or seeking to expand their current knowledge and expertise to take on higher level work..
KEY ACCOUNTABILITIES AND RESPONSIBILITIES Responsible for leading development work associated with clinical trials including: Daily 1 • Trial concept development, protocol development, CRF design for content and definitions • Review protocol and ethics applications • Undertake background research for grant applications in conjunction with CI’s • Assist in the preparation and development of grant and research funding applications and proposals • Liaise with key stakeholders through participation on sub committees for the establishment of new concepts and development of protocols for substudies • Provide draft budgets and costings relating to proposals
Responsible for conducting clinical trial operations that covers: Daily 2 • Leading project management in clinical trials practices, systems and procedures to best suit the needs of the portfolio of clinical trial/s • Resource management for the portfolio of trials • Oversight of the development of study associated documentation and materials (including study intervention e.g. drug or device supply, where appropriate) from commencement to close out of study • Monitoring and reporting on the progress of the trial/s make recommendations to the Senior Program Manager or Oncology Program Manager/Clinical Trials Director (where relevant) • Liaison with key internal and external staff and external committees ensuring study protocol compliance, milestones and timelines are met and reported on. • Organisation of meetings (including investigator meetings), presentations and reports as required • Coordination of the financial aspects of the study • Ensuring oversight of study closure both centrally and at site (including document archiving, study drug return/destruction and data system archiving) after completion or termination of the study • Adhering to CTC SOPs, SSPs and appropriate ethical and regulatory requirements
Responsible for ensuring the implementation of the ethics and regulatory requirements of clinical As 3 trial/s including: required • Ensuring compliance with the different regulatory requirements and expectations associated with a multi-site or international study • Initiate initial approvals for the lead site • Instigating protocol amendments and updates for ethics as required
Responsible for the oversight of the management of trial data including: Daily 4 • Review of the data systems in collaboration with clinical data managers • Review of the planned data collection, cleaning and reporting on a regular and scheduled basis • provision of final data sets for analyses, reporting and publication • Ensuring the confidentiality of patient databases and related clinical trials information • Liaise with trails staff, clinicians and statisticians to review requirements for central outcome review
Responsible for the oversight of monitoring associated with the trial/s or study including: As 5 • Plan, prepare and conduct on site monitoring visits with the Trial Coordinator required • Oversight of centralised monitoring activities in compliance with the monitoring plan • Escalating any compliance or audit risks to Senior Program Manager and/or Oncology Program Manager/Clinical Trials Director for consultation and review
Responsible for administrative and other support tasks associated with clinical trials including: As 6 required
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• The mentoring of other trials staff e.g. Trial Coordinators, Clinical Trial Assistants • Line manage team members and ensure that PM&D practices are adopted and implemented. • Attendance at all mandatory CTC training sessions and staff meetings • Leading CTC training sessions and staff meetings as required • Implement change management requirements and work practice improvements with respect to current CTC clinical trials practices • Contribute as a CTC member to future strategic directions of the CTC • Promote and maintain a safe, ethical and equitable work environment • Undertake any other duties relevant and appropriate to this level
KEY RELATIONSHIPS INTERNAL
MAIN CONTACT FREQUENCY PURPOSE
Senior Trial Operations staff regularly Obtain advice and assistance, and to provide regular reporting on the Matrix managers progress of trials and studies.
Clinical Data Management staff Obtain resources needed to support clinical trials, including ethics approvals, Biostatisticians contracts and other negotiations associated with trials University of Sydney Implement and report on statistical and clinical data management aspects of the trial
EXTERNAL
MAIN CONTACT FREQUENCY PURPOSE
Site Staff and clinicians regularly Ensure site staff are implementing the trial in accordance with GCP, undertake Trial Management Committee members monitoring and data management aspects of the clinical trial External Ethics and Regulatory authorities Provide feedback and reporting on study and trial progress
DECISION MAKING AND DELEGATIONS OF AUTHORITY The Associate Oncology Program Manager independently manages resources related to the project or project/s which includes line management, adapting and applying CTC SOP’s and University policies, the trial protocol/s and other regulatory requirements and seeks the advice of the Program Manager/Clinical Trials Director (as appropriate) to apply any new or revised procedures or practices to meet the needs of the trial/s.
POSITION DIMENSIONS STAFF DATA
NUMBER OF DIRECT 1-8 staff REPORTS TO THIS POSITION,
Updated 23 June 2017 Page 3
CLASSIFICATION AND NUMBER OF INCUMBENTS.
NUMBER OF REPORTS VIA 0-3 staff SUBORDINATES (INDIRECTLY) TO THIS POSITION, CLASSIFICATION AND NUMBER OF INCUMBENTS.
FACULTY/PSU SIZE 1650
SCHOOL/DEPARTMENT SIZE CTC has approximately 150 staff
FINANCIAL DATA
SALARY BUDGET Yes
NON-SALARY BUDGET Yes
GRANT BUDGET Upto $1M
OTHER AMOUNTS Co-ordinate site payments for patient recruitment
KNOWLEDGE, SKILLS, EXPERIENCE AND QUALIFICATIONS CRITERIA ESSENTIAL DESIRABLE
Highly developed project planning, coordination, organisation and time management skills.
High-level interpersonal skills and proven ability to work strategically with key staff.
High level computing skills (including databases in a windows environment, spreadsheets and word-processing).
Proven ability to identify problems, make recommendations and implement appropriate solutions.
Well-developed written and verbal communication, consultation and interpersonal skills.
Demonstrated ability to effectively work as part of a team, and to support and develop team members in their activities and professional development.
Demonstrated ability to maintain high work standards with minimal supervision, and ensure that other team members maintain and implement SOPs.
Demonstrated attention to detail and accuracy.
Previous experience in clinical trial monitoring within an academic, contract research organisation or pharmaceutical environment or equivalent.
Degree in health science or allied health field or similar education/training and relevant experience.
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Detailed knowledge of clinical research practices, including an understanding of the contractual obligations of clinical trials. Knowledge of, Good Clinical Practice guidelines. Ability to apply quality control procedures.
Ability and willingness to travel.
EQUAL EMPLOYMENT OPPORTUNITY / AFFIRMATIVE ACTION Demonstrated understanding of the incorporation into University life of the principles of Equal Employment Opportunity and Affirmative Action; and ability to work positively with staff and students from a diverse range of backgrounds.
OCCUPATIONAL HEALTH AND SAFETY Understand your OHS responsibilities and actively ensure the health, safety and wellbeing of yourself and others at work in accordance with your delegated authority, as described in the University OHS Policy and Guidelines.
SIGNATURE LINE MANAGER Clinical Trials Director
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DATE
DELEGATED OFFICER Human Resources Manager
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