Job details

Location
Melbourne, Victoria
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35427_1604467793
Contact
Maddy Rhodes-Laird
Contact email
Email Maddy
Contact phone
+61399387101
Posted
20 days ago

Job details

Location
Melbourne, Victoria
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35427_1604467793
Contact
Maddy Rhodes-Laird
Contact email
Email Maddy
Contact phone
+61399387101
Posted
20 days ago

About the company

A leading medical device company focused on producing advanced wound management products resulting in improved quality of life for the thousands of people impacted by wounds.

About the opportunity

The Clinical Study Manager is responsible for delivering clinical research projects and utilising clinical systems (CTMS, eTMF, EDC) to ensure all trials, within responsibility, are designed and delivered against agreed project milestones and to expected quality.

Duties

  • Support the development and implementation of clinical research standards, to add value to the business and improve service levels.
  • Liaise with and oversee vendors and/or Contract Research Organisations (CROs), ensuring appropriate approvals are gained and procedures followed.
  • Responsible for ensuring that clinical study related activities are carried out in accordance with the appropriate Good Clinical Practice (GCP) guidelines. This will usually be ICH GCP for medicines and ISO 14155 for Medical Devices, within the ISO9001 quality system.
  • Maintain an up-to-date knowledge of franchise area of speciality. Develop and maintain professional relationships with existing and new clinical experts.
  • Assist with estimation of costs of proposed trials, recording spends during projects, and manage against budget.
  • Promote health and safety policies and procedures to encourage a safe working environment.
  • Perform all activities in compliance with relevant Quality Systems Standards, SOPs and GPPs.

Skills and Experience

  • Bachelors Degree in Life Science, or have a nursing background with a track record in research.
  • Relevant work experience is required, ideally experience in medical devices research, and experience working to compliance with ISO14155
  • Knowledge of clinical study processes and an understanding of study execution

Culture

Inclusive, supportive and mature culture

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