Clinical Trials Manager – Swisse

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Job no: 492470
Work type: Full time
Location: Victoria
Categories: Science and Regulatory

Longing for a career, not a job, working with a team of people who are dedicated to creating premium quality, scientifically validated natural health products and love making people healthier and happier?

Swisse Wellness could be it!

With over 40 years’ experience in the Wellness sector, we are a leading Wellness brand in Australia. From our vitamins and supplements, to our superfoods, sports nutrition and skincare ranges, when you work for Swisse, you are working across multiple wellness categories, full of premium quality products all formulated to help our customers “Celebrate Life Every Day”!

THE ROLE:

This role, reporting to the Head of Research, will be responsible for the operational management and oversight of clinical trials within Swisse. The successful candidate will be responsible for coordinating all aspects of the company’s clinical trials, including their budgets, protocols, and documentation, and will serve as a communication liaison between all stakeholders (eg, suppliers, key opinion leaders, CRO’s, academic collaborators) involved in the studies. We seek a candidate with strong validation, technical and interpersonal skills gained in the Pharma/OTC/Complementary Medicine/Biotech sector to lead the clinical team.

KEY RESPONSIBILITIES:

  • Identify and Engage CROs, third party suppliers to conduct and support clinical trials
  • Oversee and manage performance of CROs, third party suppliers, to ensure compliance with study protocol, ICH GCP and regulatory standards
  • Ensure monitoring  of investigational sites
  • Manage the development of study protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Manage the development of key study plans; Clinical Monitoring Plan, Data Management Plans, Medical Monitoring Plans, Statistical Analysis Plan
  • Management of key opinion leaders and key academic investigators
  • Management of IRB/HREC submissions and associated requirements
  • Negotiate and manage the budget and payments for investigator sites
  • Line Management and training of CRAs

EXPERIENCE AND SKILLS:

  • At least 6-8 years Clinical operations work experience in a health-related industry
  • Experience working at a senior level in the clinical trials environment
  • Working knowledge of GCP/ICH guidelines and the clinical development process
  • Demonstrated leadership of a complex programme of work
  • Experience in managing vendors, including performance assessments and total financial management
  • Strong interpersonal, and verbal and written communication skills
  • Strong organisational skills
  • Ability to motivate a team to work effectively in a changing environment
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Proficient with MS Word, Excel and PowerPoint.
  • Cross-functional team leadership experience preferred (at least 2 years)

Of vital importance is that you will be a solutions-orientated and self-motivated person who will possess an abundance of positivity, initiative and a passion for making “People Healthier and Happier as well as demonstrate Swisse Wellness’ Team Spirit to “Celebrate Life Every Day!

Does this role sound perfect for you? If so, please ‘Apply Now’ by submitting your cover letter (essential) and CV to the Swisse team.

Advertised: AUS Eastern Standard Time
Applications close: AUS Eastern Standard Time

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