In attracting talent, CNS positions itself as a versatile employer. We offer not only career opportunities for professionals with different backgrounds, operating at various locations around Australia, New Zealand, the UK and the USA, but also provide a workplace that is based on strong values and a unique Employee Value Proposition. The level of engagement between CNS and its team members is at a very high level, as confirmed through our yearly employee engagement survey.

Professionals (choose to) work at CNS because of:

  • The culture

  • A work environment that is based on trust

  • Being treated as a professional

  • The respect for work/life balance

  • The small size and composition

  • Career opportunities and the successful track record

Current Career Opportunities:

 

QA Associate II – Full time or 0.8 FTE – Brisbane based

Responsibilities will include:

  • Perform quality reviews of medical writing documents
  • Coordinate and support client audits, development of quality plans and SOPs
  • Conduct review and approval of vendors and manage the approved vendor list
  • Ongoing development and maintenance of the CNS quality management system with a focus on continuous process improvement
  • Maintain awareness of the noncompliance reporting tracking system
  • Support document control in the management of quality documents

Experience:

  • Degree in life sciences, biomedical sciences, nursing or pharmacy preferred
  • At least 2 years' experience within a quality role, including GCP experience
  • Fluency in English and excellent verbal and written communication skills are essential
  • Adaptability, team work and collaboration are essential

So what’s in it for you?

  • Opportunity to become more involved with auditing
  • Rapidly growing, successful company creating ongoing opportunities for career development
  • International client base of cutting edge biotechnology companies at the forefront of scientific research. 

 

Regulatory Medical Writer - Office or Home Based Australia Wide (Full time or 0.8 FTE) 

We are currently looking for an experienced Regulatory Medical Writer to join our expanding team.

Responsibilities will include:

  • Preparation of clinical and regulatory documents, including but not limited to integrated statistical/clinical reports, protocols, investigator brochures, regulatory submissions, manuscripts for publication and other documents as required.
  • Liaison with clients, external consultants, colleagues and review current literature sources to ensure the document is developed in alignment with the client's goals, local regulations, Good Clinical Practice (GCP).
  • Working with cutting edge early phase technology across multiple therapeutic areas based on local and international client requirements. Occasional travel may be required.

Experience:

  • Qualifications required are a life science focused BSc (or equivalent), and a higher degree (e.g. a life science focused MSc or PhD).
  • Preferably 2-3 years practical/technical experience in product development from working within SME biotech
  • A good understanding of drug development is essential and general awareness of regulatory affairs is sufficient but more detailed insight into the regulatory environment for medicinal products would be an advantage
  • Excellent verbal and written communication skills are essential
  • Proactivity, adaptability, team work and collaboration are essential

 

Statistical Programmers - Office or Home Based Australia Wide (Full time or 0.8 FTE) 

We are currently recruiting for 2 Statistical Programmers, office or home based across Australia.

Responsibilities will include:

  • Provide input into statistical analysis plans with respect to presentation of data and results (tables, listings, figures) and advise project staff with requirements in relation to data collection, storage and tabulation (CDASH, SDTM, ADaM)
  • Develop and validate SAS programs for the tabulation of data, preparation of subject listings, graphical output and statistical analysis of data
  • Develop and validate SAS programs for multivariate data checking of CRF and Non-CRF (external) data by Data Management
  • Develop and maintain a library of validated programs based on CDISC (CDASH, SDTM, ADAM), and regulatory guidance for data submissions, in particular FDA
  • Act as Project Programmer for assigned projects involving multiple studies, and ensure consistency in data structuring and presentation
  • Act as mentor to junior statistical programmers and conduct training activities
  • Assist clinical data management in developing clinical databases and eCRF’s for data capture and cleaning that are compliant with CDASH/CDISC requirements.

Experience:

  • Degree in biostatistics, computer science or life sciences with demonstrated programming experience in the fields of biostatistics or pharmacometrics
  • At least 2 years experience as a Statistical Programmer within a CRO, pharmaceutical or biotechnology company
  • High level of proficiency with SAS software, R, and other statistical analysis or data visualisation software packages
  • Fluency in English and excellent verbal and written communication skills are essential
  • Adaptability, team work and collaboration are essential.

 

CRA II or Senior CRA - Home Based in Auckland, NZ (Full time or 0.8 FTE)

Due to ongoing growth, we are looking for an experienced CRA to join our New Zealand team.

Responsibilities will include:

  • Contribute to study feasibility activities and complete regulatory and ethics committee applications
  • Support site start up activities through collection of essential documents for the TMF, collation and review of site activation package, drafting of site training material and provide input to study plans and documents
  • Conduct site monitoring visits according to contract requirements, maintain adequate study supplies, ensure accurate maintenance of the trial master file
  • Develop recruitment strategies with the study team and implement at site
  • Management of site close out activities in conjunction with the study team.

Required experience:

  • At least 2 years’ experience as a CRA
  • Experience across phase I and II would be an advantage
  • Willingness to travel to sites across New Zealand.

 

CRA II or Senior CRA - Melbourne  (Freelance)

Due to ongoing growth, we are looking for a contract CRA to provide monitoring support to Melbourne sites on a 6 month contract. 

Responsibilities will include:

  • Contribute to study feasibility activities and complete regulatory and ethics committee applications
  • Support site start up activities through collection of essential documents for the TMF, collation and review of site activation package, drafting of site training material and provide input to study plans and documents
  • Conduct site monitoring visits according to contract requirements, maintain adequate study supplies, ensure accurate maintenance of the trial master file 
  • Develop recruitment strategies with the study team and implement at site
  • Management of site close out activities in conjunction with the study team.


Required experience:

  • At least 5 years’ experience as a CRA including strong phase I & II experience
  • Must have monitoring experience of phase I trials
  • Willingness to travel to local Melbourne sites.

 

CRA II or Senior CRA - Melbourne or Sydney (Permanent)

Due to continued success, we are looking for an experienced CRA II /Senior CRA to join our expanding team.

Responsibilities will include:

  • Contribute to study feasibility activities and complete regulatory and ethics committee applications
  • Support site start up activities through collection of essential documents for the TMF, collation and review of site activation package, drafting of site training material and provide input to study plans and documents
  • Conduct site monitoring visits according to contract requirements, maintain adequate study supplies, ensure accurate maintenance of the trial master file
  • Develop recruitment strategies with the study team and implement at site
  • Management of site close out activities in conjunction with the study team.

pdfPlease click here to view the full position description39.22 KB

 

Like to apply?

Please submit your CV to the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it. attention Director Human Resources.
CNS welcomes (un)solicited CVs from motivated professionals wishing to join any of our experienced consulting and operational teams located throughout our Australian, New Zealand, USA or UK offices.
Only applicants who are currently in Australia, New Zealand, the UK or USA and have a legal entitlement to work will be considered. For all of our vacancies, fluency in English is an absolute requirement.