A new opportunity has now become available for an Associate Clinical Project Manager / Senior Clinical Research Associate to join our Australia team in our Sydney office in a fixed term contract until June 2021. Within the role you will be responsible for the local (ANZ) management of clinical trial activities for assigned projects and support the Global Clinical Project Manager in the execution of global clinical investigations.
In this initial 7 month role you will be responsible for:
· Development and review of study materials to ensure alignment to clinical investigation plan, standard operating procedures, and local regulations.
· Participate in project planning for streamlined execution internally and across study sites
· Monitors the conduct of clinical trials and compliance with established standards, protocol and timelines to ensure integrity
· Oversight of trial site monitors, including review of clinical monitoring reports
· Follow standards for deviation and adverse event (safety) reporting
· Assist in management of overall trial timeline and budget and ensure potential risks are escalated
· Develop and utilise tools to assist in analysing and planning for costs, resources and performance.
· Follow relevant procedures and guidelines in order to deliver quality clinical evidence.
You Bring Your Skills and Experience
As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
· Bachelor’s degree in biology, health, bioengineering or other life sciences
· Proven experience as a Clinical Research Associate
· 1+ years CPM (or similar) / study leadership experience
· Excellent communication skills and good interpersonal relationships.
· Ability to work independently, coupled with management and organizational skills.
· Meticulous and detail oriented.
· Understanding of the regulatory context, Good Clinical Practices, ISO 14155 and standard operating procedures.
· Experience writing scientific documents
· Experience working in matrix structures
This is your chance to be part of a premier organisation with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).