About the company
A bio-pharmaceutical company engaged in the research, development, manufacture and supply of medicines that aim to make a real difference to the lives of Australians
About the opportunity
The Clinical Project Manager will lead the local study teams to deliver committed components of clinical studies according to agreed resources, budget and timelines.
Overall responsibility for the study commitments within the country, for timely delivery of data to required quality.
Lead Local Study Team(s) consisting of monitors and study administrator(s).
Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
Perform any required co-monitoring & QC visits with study monitor(s)
Proactively identify and facilitate resolution of complex study problems and issues.
Organise regular Local Study Team meetings on an agenda driven basis.
Actively work towards achieving good personal relationships with all Local Study Team members.
Report study progress/update to the Study Leader/Team
Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
Skills and Experience
Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
Minimum 3 years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
Excellent knowledge of spoken and written English.
Good ability to learn and to adapt to work with IT systems.
How to Apply
Click apply or contact Christine Bristol, Executive Consultant on 02 8877 8766 for a confidential discussion.
( SK924529A )
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About the Company Our client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company covers all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.