Medical Monitor - Australia

Premier Research is looking for a Medical Monitor - Australia to join our Medical Affairs team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech™. Join us and build your future here.What You'll Be Doing

• Conducts medical data review and generates data queries
• Ensures compliance with and adherence to all internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOPs applicable for specific projects.
• Provides support to Medical Directors with their Medical Monitoring activities.
• Initiates medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements.
• Writes and reviews Medical Monitoring Plans.
• Reviews budget and scope of medical team’s responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team.
• Tracks study progress, proactively resolves issues, and proposes corrective action to project team/clients.
• Processes and addresses protocol non-compliances at Investigative sites and ensures adherence to ethical guidelines
• Collaborates with Medical Directors on the medical-operational aspects of complex clinical studies
• Attends Investigator Meetings and interacts with Investigative site staff and client representatives
• Is a point of contact and knowledge resource for Medical Directors to consult with on study-specific drug/device medical activities
• Works closely with Medical Directors/Investigative Sites/CRAs to document and assist with resolution of clinical issues, e.g. continuing eligibility queries
• Reviews study documentation (e.g. budget, protocol, CRF, DSMB charter, etc.)
• Supports implementation and use of new technology tools
• Prepares for audits and inspections by sponsors or regulatory agencies
• Participates in internal and external project team and client meetings
• Represents the department and interfaces with other departments, as needed (e.g. with data management, clinical operations, etc.)
• Ensures activities are carried out to a high standard and as efficiently as possible with proactivity and customer focused delivery
• Reviews and QCs documents and work of other associates, as needed
• Mentors other more junior members of the team
• Participates in corporate initiatives and actions that ensure the continued success of the company
• Supports PV activities as needed

What We Are Searching For

• Graduate in medicine
• Extensive clinical practice experience in oncology is preferred (Board certification or equivalent not required).
• CRO experience in an alternative function is preferred (e.g. CRA, data management)
• 1- 2 years in a relevant pharma or medical related field or role, e.g. CRA, Pharmacy etc.
• Knowledge of ICH / GCP regulations
• Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
• Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
• Excellent organizational and time-management skills, able to prioritize workload to meet deadlines.
• Is customer service focused in approach to work both internally and externally.