Medical Monitor (Australia-Wide)

Medical Monitor (Australia-Wide)

• Location
• Sydney NSW, Australia
• Requisition Number
• Remote

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation.

The Medical Monitor (MM) is responsible for the delivery of medical monitoring services, including, but not limited to, working with clinical project teams to monitor the safety of ongoing studies, and support database locks. The MM will work with the clinical teams to review the safety data including review of MedWatch / CIOMS forms.

This individual must have the ability to work and communicate efficiently with internal and external partners. This individual must possess strong verbal and written communication competencies as well as interpersonal skills with experience participating on project teams, coordinating safety activities, and adhering to tight

timelines. The MM will attend regularly scheduled meetings as required and respond to site, sponsor and Health Authority questions. They will attend and present at Investigator meetings, review CRFs, present study updates as needed, train in-house staff and project teams, design and implement safety monitoring plans, conduct data base listings (DBL) final reviews, review blinded tables, listing & figures (TLFs), review protocol deviations, and participate in all DBL meetings as assigned. The MM will review final TLFs, work with the medical writer(s) to review & revise Clinical Study Report (CSR) documents, review discussion and conclusions, and participate in comment resolution meetings. The MM may present topline results to Sponsors or Competent Authorities. Other tasks may be required as determined by the project. The position can be remote with occasional face to face meetings dependent on business needs.

a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint. The MM must be a licensed Medical Doctor (MD) or Doctor of Osteopathy (DO) preferably with experience in Oncology. A minimum of two (2) years of industry experience and in-depth knowledge of, and experience as, a medical monitor for clinical trials (Phase I - III) is necessary.

accredited university

Health Information.

management experience in the pharmaceutical industry