Medical Monitor

Job description

The Client:
Talent Quarter has recently partnered with a leading global Clinical Research Organisation (CRO). Based here in Australia, they are driven by scientific expertise and operational excellence.
With over 20 years’ experience, they operate across several geographical locations throughout Asia-Pacific, USA and Europe.
Our client provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trials.

The Role:
We are currently looking to hire a Medical Monitor / Medical Fellow to provide medical and academic input to various aspects of clinical studies. This is a fully remote role and we welcome applications from across Australia. Some of the responsibilities may include: –

• Provide medical and academic expertise for new and existing studies
• Support Endpoint Adjudication and other relevant Committees
• Offer medical input to safety and endpoints documents and to project plans and documents
• Provide clinical input into the development and/or review of study protocols, procedure manuals, data collection tools and data quality plans; Review query reports generated from project databases to identify errors and inconsistencies, as outlined in the medical monitoring plan
• Engage with ongoing, continuous support to the sites by taking and answering queries related to medical issues around patient eligibility, recruitment, treatment and management and adverse events etc. as outlined in the scope of the medical monitoring plan
• Provide clinical input into development of endpoint adjudication manuals, plans, charters, tracking tools and associated documentation
• Provide medical review and input to endpoint packages as required
• Offer clinical input to development of safety manuals, plans, charters, tracking tools and associated documentation
• Where contracted, review and provide narratives for Serious Adverse Events

The ideal candidate:
To be successful in this role, it is likely the candidate will have the following: –

• Tertiary qualifications in a related science or health care discipline
• At least 2 years of proven experience working on clinical projects within a CRO or pharmaceutical environment
• Wide therapeutic experience in renal, oncology and Phase 1 studies are a must, with other therapeutic area expertise a bonus
• Excellent organisation and problem-solving skills
• Highly developed communication skills including verbal, written, and presentation

How to apply
If the above sounds like your ideal role and you have the skills an experience as detailed above, please don’t delay and apply today. Sending your CV in a word document format. Talent Quarter – Connections with Impact.