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Clinical Study Manager

Smith & Nephew - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin


Our Purpose

Physical health is never just about our body. It’s our mind, feelings and ambitions. When something holds it back, it’s our whole life on hold.

We’re here to change that, to use technology to take the limits off living, and help other medical professionals do the same.

So that farmworkers, rugby players, grandmas and their grandkids stare down fear, see that anything’s possible, then go on stronger. Inspired by a simple promise. Two words that bring together all we do…

Life Unlimited

The Opportunity

To manage and conduct a programme of clinical studies and related clinical activities, to support product registrations, market access, claims and provide regulatory and commercial support. This role can be based in NSW or VIC.

The Key Focus Areas of the Role

  • Responsible for delivering clinical research projects and utilising clinical systems (CTMS, eTMF, EDC) to ensure all trials, within responsibility, are crafted and delivered against agreed project achievements and to expected quality.
  • Responsible for development of Investigator Brochures, monitoring plans, trial protocols, identification, and oversight of CRF and CSR development.
  • Responsible for assessment and selection of clinical trial sites and co-ordination of appropriate monitoring of study live phases.
  • Collaborate closely with and coordinate vendors and/or Contract Research Organisations (CROs), ensuring appropriate approvals are gained and procedures followed.
  • Provide professional clinical research expertise to support the Business.
  • Support the development and implementation of clinical research standards, to add value to the business and improve service levels.
  • Where appropriate, represent Global Clinical Operations at relevant cross functional project meeting(s).

The Requirements Of The Successful Candidate

  • University degree in related field, preferably in life science, or equivalent qualification
  • A track record in research
  • Advanced project management skills adequate to lead the entire process of a clinical trial
  • The individual requires knowledge of clinical study processes and an understanding of study execution.
  • An understanding of franchise area therapies and outcomes, and a strong understanding of study design and the use of evidence for decision making and commercial support is desired.
  • Well-developed skills in presenting and influencing; planning and organisation; analysis and decision making; drive for success.
  • Experience working to compliance with ISO14155.
  • Experience in medical devices would be ideal
  • Live the values of Care, Collaboration + Courage

#LifeUnlimited with S+N:

  • We’ll support you to develop your career with a mix of on the job experience, support and mentorship from colleagues and formal learning opportunities.
  • We respect that individual employees have individual needs in both their personal and professional lives and our culture encourages work/life agility.
  • Your wellness is important to us, which is why we have created a range of options to help you maintain and improve your physical, mental and financial health.

To apply, please ensure that you include a cover letter addressing it to Talent Acquisition Lead ANZ. Due to a high volume of applications, please note that only shortlisted candidates will be contacted.

Smith & Nephew is committed to helping people regain their lives by repairing and healing the human body. We believe that this can only be achieved by establishing mutually beneficial relationships with all of our stakeholders including patients, healthcare professionals, investors, and employees. If you share our passion for innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.

We continue to actively build an environment where every individual can fulfill their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. We value the diversity of our people and welcome applications from everyone.

  • We ask that agencies not reach out to the hiring managers at this stage as we will be following an internal talent acquisition process. Feel free to contact the TA ANZ team for more information.
  • Sydney, NSW

    Health, Medical & Pharmaceutical


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