Senior Clinical Project Manager - Clinical Trials
|Job Title:||Senior Clinical Project Manager - Clinical Trials|
|Location:||Sydney C B D, Australia|
|Contact Name:||Christopher Parkinson|
|Job Published:||October 15, 2019 01:23|
The Senior Clinical Project Manager is responsible for the provision of project management services and the supervision of clinical operations staff teams comprising Clinical Project Managers (CPMs), Senior Clinical Research Associates (SCRAs), Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs). Their responsibilities include staff supervision, service provision, departmental systems/procedures support and reporting.
Ensure the delivery of high-quality clinical services.
Manage and provide guidance/mentorship to CPM, CRA and CTA staff.
Monitor CPM, CRA and CTA staff competency based on the department training matrix.
Manage service deliverables, timelines, and budget in line with company Profit and Loss expectations.
Identify and assist in the management of issues arising that may affect the planned completion of client projects including provision of support, guidance and assistance (when necessary) to clinical staff to meet project milestones.
In consultation with the DCO manage the allocation of clinical operations team resources.
Autonomously manage clinical projects from commencement to completion (includes all aspects of clinical project management, e.g. preparation and review of study documents, ethics submissions, supervision of study monitoring, management of study budget, timelines and deliverables).
Develop relationships with investigators and clinical sites and oversee study feasibilities and selection of sites.
Be actively involved in the continuous improvement of company’s quality systems.
Assist with implementation of software solutions to increase efficiency, quality of Clinical Operations.
Identify training needs and recommend to the DCO appropriate staff training actions/programs.
Participate in the planning of quality assurance activities and coordinate resolution of audit findings.
Ensure ongoing quality review of study documents (monitoring reports, protocols, manuals and plans) as required including internal reviews of documents and forms.
Ordinary degree or equivalent in an appropriate discipline and appropriate industry experience.
Industry experience in appropriate positions that complement and enhance the requirements of this position (a minimum of 10 years’ experience in the biotech/pharmaceutical/CRO industry).
If you are looking for career growth and an outstanding growth chance, then please get in touch.
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