Our client is a clinical-stage medical technology company developing a first-of-its-kind treatment. Their Board of Directors and management bring extensive operational and financial experience in medical technologies and life sciences, while its Scientific Advisors hail from top universities and medical institutions globally.
Your remit will be to provide oversight of their clinical trials across Australia. You will identify and develop clinical research protocols, including but not limited to small-scale feasibility studies, reimbursement, and new indication clinical assessments. Working cross-functionally you will implement the project plans using internal and external resources to ensure success.
Review protocols, study plans, IP management plans, CSRs and all trial-related documentation.
Work on all aspects of pre and post-market clinical studies (EU, AUS and US protocols) including development of protocols, CRFs, IB, and ICF, TMF.
Collaborate with relevant staff including regulatory affairs, marketing, research & development, reimbursement and outcomes planning.
Oversight of local CRO(s) to build excellent working relationships and communication, and effective quality oversight and documentation.
Prepare clinical reports for regulatory and medical purposes.
Manage safety reporting.
Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
Proactively identify risks pertaining to clinical trial execution, providing actionable plans and mitigation strategies.
Collaborate with clinical project/program managers and clinical operations staff with execution of the study protocol.
Bachelor’s degree in science/health/medical/engineering/nursing required. Master’s degree preferred.
5+ years’ experience in clinical/scientific research, medical devices/pharmaceutical clinical trials.
2+ years’ experience working with clinical professionals in a cross-functional product development setting.
CE mark and FDA submission experience a plus.
Experience with Active Implantable Medical Devices an advantage.
Experience in a fast-paced, entrepreneurial, high-growth environment.
Excellent communication skills both verbally and written; flexibility to adapt to communicating across all stakeholder groups.
Team player with a positive constructive attitude to solve problems. Eager to learn, stress resistant, strong self-development abilities and able to work independently.
Title: Subject to level of expertise eg – Director of Clinical Operations.
Salary: Will be based on the level of experience.
Our client offers an exceptionally dynamic and progressive work environment that is at the leading edge of new innovative implantable devices development.
To join our client in this exciting opportunity please email your cover letter & CV to email@example.com. Confidential enquiries to Marilyn Jones or Mark Thomas on 1300 0 MEXEC.