Medical Monitor

3 weeks ago

Sydney, Australia Advanced Clinical Full time

Medical Monitor (Australia-Wide)

**Location**: Sydney NSW, Australia

**Requisition Number**
**351**

**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.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**
- Oversees and is responsible for the medical monitoring services on assigned projects.
- Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents.
- Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities.
- Ensures delivery of medical/clinical direction to investigative sites per contract deliverables.
- Prepares medical and safety plans for clinical trials/services. Reviews and analyzes safety and efficacy trends.
- Builds up, maintains, and develops the internal therapeutic training in their assigned studies.
- Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
- Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts.
- Oversees reviews and directs medical and safety sections of regulatory document submissions.
- May participate in Investigator meetings Team Meetings, DSMB and Safety Review Meetings
- Contributes to the development of medical-related standard procedures and working activities.
- Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review.

**QUALIFICATIONS**

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.

**EDUCATION**
- Medical Doctor (MD) or Doctor of Osteopathy (DO) from an
accredited university

**TRAINING**
- GCP (including 21 CFR 11), HIPAA - Privacy Rule and Protected
Health Information.

**CERTIFICATION**
- License to practice medicine.

**EXPERIENCE**
- Minimum of two (2) years of clinical research and medical/safety
management experience in the pharmaceutical industry

**ROLE COMPETENCIES**
- Profic

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