Study Site Management Specialist at Smith+Nephew | Sydney, New South Wales | Rezi

Study Site Management Specialist at Smith+Nephew

Study Site Management Specialist

Smith+Nephew · Sydney, New South Wales

2 months ago

Study Site Management Specialist

Smith+Nephew · Sydney, New South Wales

2 months ago
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About the Role

This role will manage the day-to-day execution of S+N sponsored studies, coordinating site management activities from selection to closure. You will act as a liaison between study sites, vendors, and cross-functional study teams, ensuring successful study execution and compliance with regulations.

Responsibilities

  • Manage the day-to-day execution of S+N sponsored studies.
  • Coordinate site management activities including selection, preparation, activation, enrollment, follow-up, and closure.
  • Collaborate with cross-functional study teams (e.g., Clinical Study Management, Data Management, CRAs, CTAs) and vendors.
  • Serve as the primary point of contact for study sites, vendors, and CTAs.
  • Develop and maintain professional relationships with study sites and vendors.
  • Develop regional study documentation such as protocols/addendums, ICFs, and local ethics/regulatory documents.
  • Conduct regional vendor qualifications and maintain vendor oversight.
  • Ensure site quality through training, site visits, compliance reviews, trending, corrective actions, and escalation.
  • Utilize study management systems for documentation, data integrity, monitoring, and issue tracking.
  • Support Clinical Study Management with budget planning, accruals, and payments.
  • Ensure study activities comply with regional regulations and GCP guidelines (ICH GCP, ISO 14155, ISO9001).
  • Develop knowledge of applicable business units.
  • Represent Global Clinical Research Operations at cross-functional project meetings.
  • Liaise with local product teams, stakeholders, and sales/marketing personnel.

Requirements

  • Bachelor of Science or greater in engineering, design, scientific, clinical subject, or related field (e.g., life sciences, nursing, pharmacy).
  • GCP qualification.
  • 3 years of relevant industry experience preferred.
  • Include a cover letter addressed to Talent Acquisition Lead ANZ.

Work Type

  • Hybrid Work Model

Experience Level

  • 3 years of relevant industry experience preferred

Education Level

  • Bachelor of Science or greater

Benefits

  • Flexible Personal/Vacation Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day

About the Company

  • Smith and Nephew develops technology to break health barriers, empowering people to accept limitless possibilities.
  • Our purpose: Life Unlimited.
  • We believe in creating the greatest good for society.
  • Our strongest investments are in our people, the patients we serve, and to the wider health of the planet and society.
  • Smith+Nephew is a global medical technology company.
  • We design and manufacture technology that takes the limits off living.
  • We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.
  • It’s our people who make Smith+Nephew a unique place.
  • We offer competitive salaries and progressive benefits.
  • Our culture is of Care, Collaboration and Courage.
  • Through a spirit of ownership and can-do attitude we work together to win.
  • We’re a company of people who care about each other, about our customers and their patients, and about our communities.
  • Together, we fulfill our shared purpose of Life Unlimited.

Equal Opportunity

  • Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving.
  • Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/