(TCV95) - Clinical Research Project Manager

(TCV95) - Clinical Research Project Manager

17 Nov
|
FLINDERS UNIVERSITY
|
Adelaide

17 Nov

FLINDERS UNIVERSITY

Adelaide

About Flinders



Our bold vision, captured in our Strategic Plan: making a Difference: The 2025 Agenda, is to be internationally recognised as a world leader in research, an innovator in contemporary education, and the source of Australia’s most enterprising graduates.



To realise this ambition, we recently made a significant organisation change to a six College structure with a professional staff and services alignment.



We recognise the key to our success is exceptional people and we’re seeking an outstanding individual to join the team of our transformed university.



Employment Type:



Fixed Term (Fixed Term)



Position Summary



Fixed-term, full-time available for 12 months



Compensation Grade:



Higher Education Officer Level 7



Salary Range:

$86,821 - $96,107 pa



Position Reports To:



Research Fellow, College of Medicine and Public Health



Under broad direction, the Clinical Research Project Manager will have primary responsibility for the management and successful delivery of cardiac clinical trials and research projects. The Project Manager will be responsible for the study initiation processes, project implementation and delivery, and for the management of participating sites and collaborator relationships. This role will be required to provide effective project management to ensure clinical trials are implemented effectively.



Key Position Responsibilities



The Clinical Research Project Manager is accountable for:



- Successful planning and executing investigator-led and/or sponsored research projects on cost, on time, at a high quality and ensuring project objectives are met.

- Successful delivery of multiple, concurrently run clinical research projects of varying size and complexity.

- Provision of guidance to project teams of varying size, comprising clinical trials staff, personnel from key stakeholders and subcontracted sites, business representatives and staff from third party suppliers.

- Establishing effective communicating channels (written and verbal), within project delivery teams, between project teams and stakeholders, including Clinicians, Investigators, Executive/Senior Management, Business partners, Project Sponsors, Project Boards, and other business representatives.

- Development of research project documentation, including participant information sheets and consent forms, ethics and governance applications, other relevant applications, research contracts and relevant budgets, study planning and education materials, presentations, and contribution to protocol and clinical study report.

- Proactively monitor and evaluate project progress and adapt strategies to enable effective and efficient research conduct and regularly report research project status and information to executive/ senior level management and other relevant stakeholders.

- Development and maintenance positive relationships and communication of professional research service expertise to other service providers both external and across the University.

- Application and establishment of the relevant and specific standards, processes, procedures and performance measures for each project, in alignment with project objectives and ICH-GCP guidelines, ensuring these are applied effectively throughout the clinical research project lifecycle.

- Contribution to the continuing improvement of project delivery standards, processes and procedures to be used throughout the project and other projects as applicable.

- In liaison with executive/ senior management, effectively forecast required project resources as well as assign and oversee tasks of junior team members where appropriate, ensuring deadlines are met.

- Management of third-party suppliers of products and services, including contract project resources.

- Development and maintenance of positive working relationships with all collaborators and delivery domains (e.g. internal and external Contracts, Finance, Ethics, Governance, Data Custodians and Management staff, Investigators, Study Coordinators, Monitors, AI and Analytical Services) to efficiently and effectively manage and minimise impact of cross domain issues.

- Preparing reports for relevant investigators, executive/senior management, clients, external stakeholders and internal governance.

- Continuing attention to detail throughout the project lifecycle, including study initiation, successful recruitment, follow-up and data reporting rates, change management, proactive problem-solving and post-project review.

- Any other responsibilities in line with the role level as assigned by the Supervisor and/or the University.



Key Position Capabilities



- A degree in health, science, or other relevant degree qualifications and/or a combination of extensive relevant clinical research services experience.

- Relevant experience in clinical research project coordination/management for the delivery of health data research projects and clinical trials in a complex, diverse and dynamic environment.

- Demonstrated experience in clinical trials, preferably in both investigator-led and industry research, with experience adapting processes and procedures to suit specific circumstances.

- Demonstrated ability to concurrently manage multiple projects as well as ability to rapidly adapt project priorities in response to changing strategic priorities.

- Demonstrated high-level organisation skills and ability to forward plan project resources, problem-solve, manage delivery schedules, deliver reports, and achieve outcomes.

- Demonstrated understanding of a wide range of project implementation and delivery methodologies and strategies and their application within ICH-GC, and ability to review, analyse and advise on outcomes of such approaches.

- Demonstrated ability to be a team player with experience in building and maintaining positive team and stakeholder relationships, managing expectations and effectively delegating tasks where appropriate.

- Well-developed interpersonal, influence and stakeholder management skills, including demonstrated ability to negotiate and communicate effectively with executive/senior management, staff, clients and other stakeholders across diverse organisations throughout project lifecycles.

- Strong written communication skills and highly developed oral presentation skills.

- An ability and desire to take initiative and proactively explore and utilise novel approaches and solutions to implementing health data science and clinical research into clinical practice.

- Experience in creation/adaptation of consent forms, ethics applications, study management plans, study status reports, and presentations.

- Specific training in clinical trial/health data project management or aspects thereof.



Please direct application enquiries to Ms Kristina Lambrakis



Information for Applicants: You are required to provide a suitability statement of no more than three pages, addressing the key capabilities of the position as outlined above. In addition, you are required to upload your CV.



A valid National Police Certificate which is satisfactory to the University will also be required before the successful applicant can commence in this position.



We are seeking to increase the diversity to improve equal opportunity outcomes for employees, and therefore we encourage female applicants, people with a disability and/or from Aboriginal or Torres Strait Islanders descent to apply.



Please note, late applications and applications sent via agencies will not be accepted.



Applications to be submitted before:



17 Nov 2020

The original job offer can be found in Kit Job:
https://www.kitjobau.com/job/8558957/tcv95-clinical-research-project-manager-adelaide/?utm_source=html

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