12 Nov
|
Planet Pharma
|
Sydney
12 Nov
Planet Pharma
Sydney
Senior Medical Monitor
Australia | Remote
The Opportunity
Our client is a growing clinical research organisation seeking an experienced physician to provide medical monitoring and safety oversight across a portfolio of clinical studies.
Working closely with investigators, sponsors, and cross-functional study teams, you will provide medical leadership throughout the lifecycle of clinical trials, ensuring participant safety, protocol compliance, and high-quality study delivery. This is an excellent opportunity for a medically qualified professional who enjoys operating in a collaborative, fast-paced clinical development environment.
Key Responsibilities
- Provide medical and safety oversight for assigned clinical trials.
- Review and contribute to study documentation, including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
- Support investigators and study teams with participant eligibility assessments and protocol-related medical queries.
- Review clinical data, medical coding outputs, safety data, and protocol deviations.
- Provide therapeutic area and protocol training to internal teams and investigator sites.
- Participate in investigator meetings, study kick-offs, data review meetings, and sponsor discussions.
- Contribute to medical monitoring plans and ongoing medical monitoring activities throughout study conduct.
- Support regulatory and ethics committee responses where medical expertise is required.
- Provide input into proposals, bid defences, and client-facing activities as required.
Experience & Qualifications
- Medical degree from a recognised institution.
- Approximately 8+ years of relevant medical experience.
- Experience supporting clinical trials within a CRO, biotechnology, pharmaceutical, or clinical research environment.
- Strong understanding of ICH-GCP and clinical trial conduct.
- Experience reviewing safety data, protocols, informed consent documents, and clinical study reports.
- Ability to work effectively with investigators, sponsors, and multidisciplinary study teams.
- Strong written and verbal communication skills.
- Fluent English required. Additional languages would be advantageous.
Ideal Profile
We are interested in physicians who combine strong clinical judgement with an understanding of clinical development and patient safety. Candidates should be comfortable operating in a matrix environment, collaborating across clinical operations, pharmacovigilance, project management, data management, biostatistics, and sponsor stakeholder groups.
Location
- Australia-based role
- Remote working environment
- Melbourne or Sydney preferred
Package
- Competitive salary and bonus package
- Adaptable working environment
- Opportunity to work on a diverse portfolio of clinical studies
📌 Medical Monitor / Senior Medical Monitor (Sydney)
🏢 Planet Pharma
📍 Sydney