Clinical Project Manager: Office or Home based within ANZ
Home or office based Clinical Project Manager focused on early phase development studies.
Summary about this job
Pharmaceuticals & Medical Devices
Company: Clinical Network Services (CNS) Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-3-2124-2472
Fax: +61-8-2001-3574
E-mail: n\a
Site: n\a
Detail information about job Clinical Project Manager: Office or Home based within ANZ. Terms and conditions vacancy
CNS is a uniquely integrated service group that goes significantly beyond the traditional CRO service, focused on broader and deeper product development. It integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical operations and biometrics teams.
We are headquartered in Brisbane, Australia with our team also located throughout Australia, New Zealand, the UK and the USA (Washington DC). In 2015 we were voted as the Australian Favourite CRO by ARCS members (as well as other third parties).
Due to continued success, we are looking for an experienced Clinical Project Manager to join our expanding team. CNS focus on early phase development and our PM’s manage full service studies.
Responsibilities will include:
- Use expertise within feasibility and start up to review site selection information and recommend sites for participation
- Lead all start up activities including management of multi-disciplinary project teams, providing technical guidance as required, review and approve site activation packages, training materials and lead the investigator meeting.
- Review and approve the protocol, CRF, Data Management Plan, Statistical Analysis Plan and Clinical Study Report
- Source and contract third part vendors where required for study supplies/services
- Oversight of all maintenance activities including vendor management, site visits, recruitment, TMF maintenance, compliant SAE reporting
- Management of close out activities, reviewing the TMF for completeness and accuracy, reconciling all project finances and oversee final ethics committee and regulatory authority reporting
- Mentoring and training of new hires
Experience
- Degree in life sciences, biomedical sciences, nursing or pharmacy preferred
- Minimum of 2 years’ experience as a clinical project manager, including experience within early phase development
- Experience managing full service studies, with oversight of cross functional project milestones
- Adaptability, team work, time management and critical thinking are essential for this role
So what’s in it for you?
- Rapidly growing, successful company creating ongoing opportunities for career development
- A strong values based organisation with a unique value proposition and high levels of staff engagement (as confirmed by Aon Hewitt annual engagement survey)
- International client base of cutting edge biotechnology companies at the forefront of scientific research.
Only applicants who are eligible to work in Australia will be considered.
No agencies have been engaged on this role and only direct applicants will be considered.
To apply please click on the apply now button and submit your cover letter and CV to Human Resources at [email protected]