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/
